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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura.
The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment.
This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).
We designed a non-inferiority trial to show that co-administered moxidectin and albendazole is non-inferior compared to co-administered ivermectin and albendazole in adolescents aged 12-19 years on Pemba Island (Tanzania). From previous studies conducted by our group, we expect similar efficacies from the combination moxidectin/ albendazole compared to ivermectin/ albendazole. However, moxidectin might be advantageous in terms of the drug's longer half-life and in areas with possible emerging ivermectin resistance. This study will allow comparing the efficacy of the two available co-administrations and will provide further insights on the potential value of moxidectin/ albendazole. Our data will pave the way for possible large scale, multi country follow-up studies. As recommended for new combination therapies, we simultaneously assess superiority of the drug combinations compared to monotherapies.
The primary objective is to demonstrate that co-administered moxidectin (8 mg) / albendazole (400 mg) is non-inferior to ivermectin (200 µg/kg) / albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in adolescents aged 12-19 years using a non-inferiority margin of 2 percentage-points.
The secondary objectives of the trial are:
The study will be carried out in adolescents aged 12-19 years attending secondary schools on Pemba Island, Tanzania. After consenting, all participants will be asked to provide two stool samples (within a maximum of 7 days) at each time-point assesment. From each stool specimen, duplicate Kato-Katz thick smears (41.7 mg each) will be prepared and read under a microscope for eggs of T. trichiura, A. lumbricoides and hookworm by experienced technicians.
After randomization, all eligible adolescents will be treated with the respective single or combination treatment regimen according to their assigned treatment arm at day 0.
All drugs will be administered in the presence of the PI and/ co-PI, and ingestion confirmed. This will be recorded with the time and date of dosing. Participants will be kept for 3 hours after treatment administration to observe any possible acute AEs and reassessment will be done at 24h post-treatment. Additionally, interviews will be conducted to determine the emergence of clinical symptoms such as headache, abdominal pain, itching, nausea, vomiting and diarrhea directly before treatment within the scope of baseline assessment. At 3 and 24 hours after treatment and retrospectively at days 14 - 21 as well as 5-6 weeks and 3 months post-treatment, participants will again be interviewed for the assessment of adverse events (AEs).
Egg reduction rate calculated from the geometric means of co-administered moxidectin/ albendazole and ivermectin/ albendazole against T. trichiura assessed at 14-21 days post-treatment is the primary endpoint in our study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: moxidectin (8 mg) / albendazole (400 mg) | Experimental | Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
|
| B: ivermectin (200 µg/kg) / albendazole (400 mg) | Active Comparator | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
|
| C: albendazole (400 mg) | Active Comparator | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® |
|
| D: ivermectin (200 µg/kg) | Active Comparator | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® |
|
| E: moxidectin (8 mg) | Active Comparator | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxidectin (8 mg) / albendazole (400 mg) | Drug | Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Egg Reduction Rate Against T. Trichiura | Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels. | 14-21 day post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Pemba | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36354034 | Derived | Welsche S, Mrimi EC, Hattendorf J, Hurlimann E, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial. Lancet Infect Dis. 2023 Mar;23(3):331-340. doi: 10.1016/S1473-3099(22)00589-8. Epub 2022 Oct 28. | |
| 34632308 |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Moxidectin (8 mg) / Albendazole (400 mg) | Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline/Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 7, 2020 |
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Open Label with masked outcomes assessors
|
| ivermectin (200 µg/kg) / albendazole (400 mg) | Drug | Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
|
|
| ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL] | Drug | Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
|
|
| ivermectin (200 µg/kg) | Drug | Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
|
|
| moxidectin (8 mg) | Drug | Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
| 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment |
| Superiority in Terms of Cure Rates (CRs) | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura. | 14-21 day post-treatment |
| Cure Rates Against T. Trichiura | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 14-21 day post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 5-6 weeks post-treatment |
| Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 5-6 weeks post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 3 months post-treatment |
| Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 3 months post-treatment |
| Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days post-treatment |
| Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 14-21 days post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 5-6 weeks post-treatment |
| Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 5-6 weeks post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 3 months post-treatment |
| Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 3 months post-treatment |
| Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days post-treatment |
| Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides. | 14-21 days post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 5-6 weeks post-treatment |
| Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 5-6 weeks post-treatment |
| Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 3 months post-treatment |
| Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | 3 months post-treatment |
| Derived |
| Welsche S, Mrimi EC, Keller L, Hurlimann E, Hofmann D, Hattendorf J, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol. Gates Open Res. 2021 Sep 27;5:106. doi: 10.12688/gatesopenres.13299.2. eCollection 2021. |
| FG001 |
| B: Ivermectin (200 µg/kg) / Albendazole (400 mg) |
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| FG002 | C: Albendazole (400 mg) | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| FG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| FG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up 1: 14-21 Days Post Treatment |
|
| Follow-up 2: 5-6 Weeks Post Treatment |
|
| Follow-up 3: 3 Months Post Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Moxidectin (8 mg) / Albendazole (400 mg) | Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| BG001 | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| BG002 | C: Albendazole (400 mg) | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| BG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| BG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Height, cm | Mean | Standard Deviation | cm |
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| Weight, kg | Mean | Standard Deviation | kg |
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| T. trichiura infection, geometric mean EPG | Geometric Mean | Standard Deviation | eggs per gram |
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| T. trichiura infection, arithmetic mean EPG | Mean | Standard Deviation | eggs per gram |
| ||||||||||
| T. trichiura infection intensity (EPG): light | T trichiura infection intensity categorised by mean EPG of stool (light 1-999, moderate 1000-9999, and heavy ≥10000) Eggs per gram (EPG) will be assessed by adding up the T. trichiura egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Count of Participants | Participants |
| ||||||||||
| T. trichiura infection intensity (EPG): moderate | T trichiura infection intensity categorised by mean EPG of stool (light 1-999, moderate 1000-9999, and heavy ≥10000) Eggs per gram (EPG) will be assessed by adding up the T. trichiura egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Count of Participants | Participants |
| ||||||||||
| T. trichiura infection intensity (EPG): heavy | T trichiura infection intensity categorised by mean EPG of stool (light 1-999, moderate 1000-9999, and heavy ≥10000) Eggs per gram (EPG) will be assessed by adding up the T. trichiura egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Count of Participants | Participants |
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| Hookworm infection, No. infected | number of infected participants | Count of Participants | Participants |
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| Hookworm infection, geometric mean EPG | number of infected participants | Geometric Mean | Standard Deviation | eggs per gram |
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| Hookworm infection, arithmetic mean EPG | number of infected participants | Mean | Standard Deviation | eggs per gram |
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| Hookworm infection intensity (EPG): light | Hookworm infection intensity is categorised by mean EPG of stool (light 1-1999, moderate 2000-3999, and heavy ≥4000). Eggs per gram (EPG) will be assessed by adding up the hookworm egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Row population is the count of participants infected with Hookworm | Count of Participants | Participants |
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| A. lumbricoides infection, No. infected | Count of Participants | Participants |
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| A. lumbricoides infection, geometric mean EPG | number of infected participants | Geometric Mean | Standard Deviation | eggs per gram |
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| A. lumbricoides infection, arithmetic mean EPG | number of infected participants | Mean | Standard Deviation | eggs per gram |
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| A. lumbricoides intensity (EPG): light | A lumbricoides infection intensity is categorised by mean EPG (light 1-4999, moderate 5000-49999, and heavy ≥50000). Eggs per gram (EPG) will be assessed by adding up the A. lumbricoides egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Row population is the count of participants infected with A. lumbricoides | Count of Participants | Participants |
| |||||||||
| A. lumbricoides infection intensity (EPG): moderate | A. lumbricoides infection intensity is categorised by mean EPG (light 1-4999, moderate 5000-49999, and heavy ≥50000). Eggs per gram (EPG) will be assessed by adding up the A. lumbricoides egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Row population is the count of participants infected with A. lumbricoides | Count of Participants | Participants |
| |||||||||
| A. lumbricoides infection intensity (EPG): heavy | A. lumbricoides infection intensity is categorised by mean EPG (light 1-4999, moderate 5000-49999, and heavy ≥50000). Eggs per gram (EPG) will be assessed by adding up the A. lumbricoides egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. | Row population is the count of participants infected with A. lumbricoides | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Egg Reduction Rate Against T. Trichiura | Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels. | Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 14-21 day post-treatment |
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| Secondary | Number of Participants With Adverse Events | The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs. | number analyzed corresponds to the number of participants assessed per time point | Posted | Count of Participants | Participants | 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment |
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| Secondary | Superiority in Terms of Cure Rates (CRs) | Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura. | Posted | Number | 95% Confidence Interval | Percentage of participants | 14-21 day post-treatment |
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| Secondary | Cure Rates Against T. Trichiura | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 14-21 days post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 14-21 day post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 5-6 weeks post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 3 months post-treatment |
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| Secondary | Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for T. trichiura at baseline and assessed at 3 months post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months post-treatment |
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| Secondary | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 14-21 days post-treatment |
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| Secondary | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at baseline and assessed at 14-21 days post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 14-21 days post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Mean number of participants found positive for hookworm at 5-6 weeks post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 5-6 weeks post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 3 months post-treatment |
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| Secondary | Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 3 months post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months post-treatment |
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| Secondary | Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 14-21 days post-treatment |
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| Secondary | Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides | Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides. | Number of participants found positive for A. lumbricoides at baseline and assessed at 14-21 days post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 14-21 days post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 5-6 weeks post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 5-6 weeks post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 5-6 weeks post-treatment |
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| Secondary | Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months | Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Geometric mean reduction in number of eggs at baseline and assessed at 3 months post-treatment | Posted | Geometric Mean | 95% Confidence Interval | Percent change | 3 months post-treatment |
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| Secondary | Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months | Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. | Number of participants found positive for hookworm at 3 months post-treatment | Posted | Number | 95% Confidence Interval | Percentage of participants | 3 months post-treatment |
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Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively
Severity grading was categorized according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Moxidectin (8 mg) / Albendazole (400 mg) | Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 moxidectin (8 mg) / albendazole (400 mg): Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 0 | 207 | 0 | 207 | 73 | 207 |
| EG001 | B: Ivermectin (200 µg/kg) / Albendazole (400 mg) | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 ivermectin (200 µg/kg) / albendazole (400 mg): Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 0 | 211 | 0 | 211 | 93 | 211 |
| EG002 | C: Albendazole (400 mg) | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 | 0 | 19 | 0 | 19 | 4 | 19 |
| EG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 | 0 | 19 | 0 | 19 | 6 | 19 |
| EG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 | 0 | 80 | 0 | 80 | 23 | 80 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Abdominal pain | General disorders | Systematic Assessment |
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| Itching | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Musculoskeletal pain | General disorders | Systematic Assessment |
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| Muscle weakness | General disorders | Systematic Assessment |
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| Rash | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Diarrhea | General disorders | Systematic Assessment |
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| Cough | General disorders | Systematic Assessment |
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| Constipation | General disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment | Adverse events assessment of self-reported fever, sleepiness, itching eyes, eye discharge, flu-like symptoms, ear pain |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jennifer Keiser | Swiss TPH | +41612848218 | jennifer.keiser@swisstph.ch |
| Dec 4, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2020 | Dec 4, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D001196 | Ascariasis |
| D006725 | Hookworm Infections |
| D006373 | Helminthiasis |
| D000724 | Ancylostomiasis |
| D007411 | Intestinal Diseases, Parasitic |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D017191 | Ascaridida Infections |
| D017190 | Secernentea Infections |
| D017206 | Strongylida Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C027837 | moxidectin |
| D015766 | Albendazole |
| D007559 | Ivermectin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
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| OG002 | C: Albendazole (400 mg) | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
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|
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 | C: Albendazole (400 mg) | Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
| OG002 |
| C: Albendazole (400 mg) |
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 |
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
|
|
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]: Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
| OG003 | D: Ivermectin (200 µg/kg) | Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® ivermectin (200 µg/kg): Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0 |
| OG004 | E: Moxidectin (8 mg) | Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 moxidectin (8 mg): Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0 |
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