Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
Not provided
Not provided
Not provided
Not provided
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among SAC receiving moxidectin/albendazole combination therapy and albendazole monotherapy.
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 moxidectin in T. trichiura infected SAC.
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. Adverse events will be compiled into frequency tables and compared between treatment groups using descriptive summary statistics.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Moxidectin 4/8 mg & Albendazole | Experimental | Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm B: Albendazole | Active Comparator | Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm C: Placebo | Placebo Comparator | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin 2 mg Oral Tablet | Drug | Tablets of 2 mg moxidectin |
| |
| 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 Moxidectin | For characterization of population pharmacokinetics (PK), moxidectin 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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40675166 | Derived | Schnoz A, Sprecher VP, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of moxidectin-albendazole combination therapy for Trichuris trichiura infections in school-aged children: a double-blind, randomised, controlled, superiority trial. Lancet Infect Dis. 2025 Dec;25(12):1325-1335. doi: 10.1016/S1473-3099(25)00344-5. Epub 2025 Jul 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Moxidectin 4/8 mg & Albendazole | Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG001 | Arm B: Albendazole | Placebo for moxidectin (2 or 4 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 Moxidectin: Placebo tablets for moxidectin |
| FG002 | Arm C: Placebo | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Placebo Moxidectin: Placebo tablets for moxidectin Placebo Albendazole: Placebo tablets for albendazole |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Moxidectin 4/8 mg & Albendazole | Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| 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
Not provided
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 | Arm A: Moxidectin 4/8 mg & Albendazole | Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
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 |
Not provided
| 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 | Apr 2, 2024 | Jul 20, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D001196 | Ascariasis |
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
Not provided
Not provided
| ID | Term |
|---|---|
| C027837 | moxidectin |
| D013607 | Tablets |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
The trial will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using appearance-matching placebos.
| Albendazole 400 mg Oral Tablet |
| Drug |
Tablets of 400 mg albendazole |
|
|
| Placebo Moxidectin | Drug | Placebo tablets for moxidectin |
|
| Placebo Albendazole | Drug | Placebo tablets for albendazole |
|
| 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 |
| Arm B: Albendazole |
Placebo for moxidectin (2 or 4 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 Moxidectin: Placebo tablets for moxidectin |
| BG002 | Arm C: Placebo | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Placebo Moxidectin: Placebo tablets for moxidectin Placebo Albendazole: Placebo tablets for albendazole |
| BG003 | 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 |
|
Placebo for moxidectin (2 or 4 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 Moxidectin: Placebo tablets for moxidectin
| OG002 | Arm C: Placebo | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Placebo Moxidectin: Placebo tablets for moxidectin Placebo Albendazole: Placebo tablets for 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 Moxidectin | For characterization of population pharmacokinetics (PK), moxidectin 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 |
| 0 |
| 114 |
| 0 |
| 114 |
| 10 |
| 114 |
| EG001 | Arm B: Albendazole | Placebo for moxidectin (2 or 4 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 Moxidectin: Placebo tablets for moxidectin | 0 | 74 | 0 | 74 | 3 | 74 |
| EG002 | Arm C: Placebo | Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Placebo Moxidectin: Placebo tablets for moxidectin Placebo Albendazole: Placebo tablets for albendazole | 0 | 36 | 0 | 36 | 3 | 36 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment | Non-systematic collection of symptoms, including cough, flu, pustules, red eyes, rhinorrhoea. |
|
Not provided
Not provided
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017191 | Ascaridida Infections |
| D017190 | Secernentea Infections |
| D017206 | Strongylida Infections |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Moderate infection (1000-9999 EPG) |
|
| Heavy infection (>9999 EPG) |
|
|
| 3 hours: Nausea |
|
| 3 hours: Vomiting |
|
| 3 hours: Dizziness |
|
| 3 hours: Headache |
|
| 24 hours: Abdominal pain |
|
| 24 hours: Diarrhoea |
|
| 24 hours: Nausea |
|
| 24 hours: Vomiting |
|
| 24 hours: Dizziness |
|
| 24 hours: Headache |
|
| 14-21 days: Abdominal pain |
|
| 14-21 days: Diarrhoea |
|
| 14-21 days: Nausea |
|
| 14-21 days: Vomiting |
|
| 14-21 days: Dizziness |
|
| 14-21 days: Headache |
|