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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed oro-dispersible tablets (ODTs) and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among PSAC receiving different doses of ivermectin.
The secondary objectives of the trial are to compare the egg reduction rates (ERRs) of the treatment regimens against T. trichiura, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens.
In addition, this study aims to characterize population pharmacokinetics of the ivermectin ODTs compared to standard tablets in T. trichiura infected individuals, and to assess the acceptability of the treatments.
After obtaining informed consent from parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which will be collected, if possible, on two consecutive days or otherwise within a maximum of 5 days. All stool samples will be examined with duplicated Kato-Katz thick smears by experienced laboratory technicians.
Randomization of participants into the six treatment arms will be stratified according to intensity of infection and age. All participants will be interviewed before treatment, and at 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment. Differences among CRs between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight). Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.Using the DoseFinding package of the statistical software environment R, Emax models will be implemented to predict the dose-response curves based on CRs and ERRs.
Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Ivermectin ODT Placebo & Albendazole | Placebo Comparator | Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Experimental | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm E: Ivermectin ODT 400 µg/kg & Albendazole |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin 1.5 mg ODT | Drug | Oro-dispersible tablets of 1.5 mg ivermectin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure Rate (CR) Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Concentration of Ivermectin | For characterization of population pharmacokinetics (PK), ivermectin concentration will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. | 0 to 24 hours post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40975108 | Derived | Sprecher VP, Schnoz A, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of orodispersible ivermectin co-administered with albendazole for Trichuris trichiura infections in preschool-aged children in Tanzania: a single-blind, randomised, controlled, dose-ranging, phase 2 trial. Lancet Infect Dis. 2026 Feb;26(2):160-169. doi: 10.1016/S1473-3099(25)00472-4. Epub 2025 Sep 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Ivermectin ODT Placebo & Albendazole | Placebo for ivermectin (oro-dispersible tablets, ODT) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Placebo Ivermectin ODT: Placebo for ivermectin ODT |
| FG001 | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG002 | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG003 | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG004 | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG005 | Arm F: Ivermectin Standard Tablets & Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Ivermectin ODT Placebo & Albendazole | Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Placebo Ivermectin ODT: Placebo for ivermectin ODT |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cure Rate (CR) Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | Available case population | Posted | Number | 95% Confidence Interval | percentage of participants cured (%) | 14-21 days post-treatment |
|
2-3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Ivermectin ODT Placebo & Albendazole | Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Placebo Ivermectin ODT: Placebo for ivermectin ODT |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Jennifer Keiser | Swiss Tropical and Public Health Institute | +41 61 284 82 18 | jennifer.keiser@swisstph.ch |
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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 | May 8, 2024 | Jul 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D001196 | Ascariasis |
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D015766 | Albendazole |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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Single (Participant) Treatment allocation will be masked using appearance-matched placebos.
Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm F: Ivermectin standard tablets & Albendazole | Active Comparator | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Ivermectin 3 mg Oral Tablet | Drug | Tablets of 3 mg ivermectin |
|
|
| Albendazole 400 mg Oral Tablet | Drug | Tablets of 400 mg albendazole |
|
|
| Placebo Ivermectin ODT | Drug | Placebo for ivermectin ODT |
|
| Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 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 Rate (CR) Against A. Lumbricoides | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment |
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 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 |
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 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 Rate (CR) Against Hookworm | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment |
| Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 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 |
| Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 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 |
| Number of Participants Reporting Adverse Events (AEs) | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. | 3 hours, 24 hours and 14-21 days post-treatment |
| Acceptability of ODT Assessed by Visual Analogue Scale (0-100 mm) | To determine the acceptability of ivermectin ODTs compared to standard tablets, the palatability of each formulation will be rated by children aged 4-5 years using a visual analogue scale with continuous scores from 0 mm (worst taste) to 100 mm (best taste). | 15 min post-treatment |
| Arm B: Ivermectin ODT 100 µg/kg & Albendazole |
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG002 | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG003 | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG004 | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG005 | Arm F: Ivermectin Standard Tablets & Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Trichuris trichiura infection intensity | Count of Participants | Participants |
|
| Ascaris lumbricoides co-infection | Count of Participants | Participants |
|
| Hookworm co-infection | Count of Participants | Participants |
|
Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin
Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole
| OG002 | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| OG003 | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| OG004 | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| OG005 | Arm F: Ivermectin Standard Tablets & Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
|
|
| Secondary | Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 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. | Available case population. | Posted | Geometric Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 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. | Available case population. | Posted | Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Cure Rate (CR) Against A. Lumbricoides | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | Posted | Number | 95% Confidence Interval | percentage of participants cured (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 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. | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | Posted | Geometric Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 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. | Subset of participants co-infected with A. lumbricoides at baseline and providing follow-up data. | Posted | Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Cure Rate (CR) Against Hookworm | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | Posted | Number | 95% Confidence Interval | percentage of participants cured (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 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. | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | Posted | Geometric Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 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. | Subset of participants co-infected with hookworm at baseline and providing follow-up data. | Posted | Mean | 95% Confidence Interval | percent change in egg counts (%) | 14-21 days post-treatment |
|
|
|
| Secondary | Number of Participants Reporting Adverse Events (AEs) | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. | All participants receiving treatment. | Posted | Number | participants | 3 hours, 24 hours and 14-21 days post-treatment |
|
|
|
| Other Pre-specified | Blood Concentration of Ivermectin | For characterization of population pharmacokinetics (PK), ivermectin concentration will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. | Not Posted | 0 to 24 hours post-treatment | Participants |
| Other Pre-specified | Acceptability of ODT Assessed by Visual Analogue Scale (0-100 mm) | To determine the acceptability of ivermectin ODTs compared to standard tablets, the palatability of each formulation will be rated by children aged 4-5 years using a visual analogue scale with continuous scores from 0 mm (worst taste) to 100 mm (best taste). | Not Posted | 15 min post-treatment | Participants |
| 0 |
| 43 |
| 0 |
| 43 |
| 4 |
| 43 |
| EG001 | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Combination therapy of ivermectin (100 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 44 | 0 | 44 | 3 | 44 |
| EG002 | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Combination therapy of ivermectin (200 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 42 | 0 | 42 | 1 | 42 |
| EG003 | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Combination therapy of ivermectin (300 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 44 | 0 | 44 | 1 | 44 |
| EG004 | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Combination therapy of ivermectin (400 µg/kg using oro-dispersible tablets of 1.5 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 1.5 mg ODT: Oro-dispersible tablets of 1.5 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 44 | 0 | 44 | 7 | 44 |
| EG005 | Arm F: Ivermectin Standard Tablets & Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 43 | 0 | 43 | 1 | 43 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017191 | Ascaridida Infections |
| D017190 | Secernentea Infections |
| D017206 | Strongylida Infections |
| D002219 |
| Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| Male |
|
| Moderate (1000-9999 EPG) |
|
| Heavy (>9999 EPG) |
|
| 3 hours: Diarrhoea |
|
| 3 hours: Vomiting |
|
| 24 hours: Abdominal pain |
|
| 24 hours: Diarrhoea |
|
| 24 hours: Vomiting |
|
| 14-21 days: Abdominal pain |
|
| 14-21 days: Diarrhoea |
|
| 14-21 days: Vomiting |
|