A Phase 2 interventional study of Ivermectin 1.5 mg ODT and Ivermectin 3 mg Oral Tablet in Trichuriasis, Ascariasis and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Tanzania. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment
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.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 260 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo for ivermectin (oro-dispersible tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Drug: Albendazole 400 mg Oral Tablet · Drug: Placebo Ivermectin ODT
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
Drug: Ivermectin 1.5 mg ODT · Drug: Albendazole 400 mg Oral Tablet
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
Drug: Ivermectin 1.5 mg ODT · Drug: Albendazole 400 mg Oral Tablet
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
Drug: Ivermectin 1.5 mg ODT · Drug: Albendazole 400 mg Oral Tablet
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
Drug: Ivermectin 1.5 mg ODT · Drug: Albendazole 400 mg Oral Tablet
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
Drug: Ivermectin 3 mg Oral Tablet · Drug: Albendazole 400 mg Oral Tablet
Oro-dispersible tablets of 1.5 mg ivermectin
Tablets of 3 mg ivermectin
Also known as: Stromectol®
Tablets of 400 mg albendazole
Also known as: Zentel®
Placebo for ivermectin ODT
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.
Time frame: 14-21 days post-treatment
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.
Time frame: 14-21 days post-treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours, 24 hours and 14-21 days post-treatment
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.
Time frame: 0 to 24 hours 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).
Time frame: 15 min post-treatment
| Milestone | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Started | 43 | 44 | 42 | 44 | 44 | 43 |
| Completed | 40 | 42 | 42 | 39 | 40 | 42 |
| Not completed | 3 | 2 | 0 | 5 | 4 | 1 |
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
| percentage of participants cured (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Cure Rate (CR) Against T. Trichiura | 17.5 (7.3 to 32.8) | 50.0 (34.2 to 65.8) | 83.3 (68.6 to 93.0) | 84.6 (69.5 to 94.1) | 90.0 (76.3 to 97.2) | 73.8 (58.0 to 86.1) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 65.5 (30.5 to 83.5) | 97.2 (93.9 to 98.8) | 99.7 (99.2 to 99.9) | 99.7 (99.1 to 99.9) | 99.8 (99.5 to 100.0) | 99.2 (97.9 to 99.8) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 30.2 (-11.0 to 54.2) | 88.3 (79.6 to 94.3) | 98.9 (96.8 to 99.7) | 97.9 (94.4 to 99.6) | 98.3 (95.6 to 99.9) | 79.8 (38.7 to 97.2) |
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
| percentage of participants cured (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Cure Rate (CR) Against A. Lumbricoides | 100.0 (69.2 to 100.0) | 100.0 (75.3 to 100.0) | 100.0 (63.1 to 100.0) | 100.0 (59.0 to 100.0) | 100.0 (59.0 to 100.0) | 100.0 (66.4 to 100.0) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) | 100.0 (100.0 to 100.0) |
The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment.
| percentage of participants cured (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Cure Rate (CR) Against Hookworm | 100.0 (63.1 to 100.0) | 45.5 (16.8 to 76.6) | 62.5 (24.5 to 91.5) | 70.0 (34.8 to 93.3) | 71.4 (29.0 to 96.3) | 57.1 (18.4 to 90.1) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 100.0 (100.0 to 100.0) | 93.1 (78.4 to 98.2) | 97.4 (83.0 to 99.8) | 97.9 (92.4 to 100.0) | 98.6 (94.0 to 100.0) | 97.1 (87.4 to 99.7) |
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.
| percent change in egg counts (%) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 100.0 (100.0 to 100.0) | 85.7 (54.4 to 93.1) | 88.9 (66.7 to 99.2) | 92.8 (83.6 to 100.0) | 92.2 (82.8 to 100.0) | 62.3 (38.6 to 98.6) |
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.
| participants | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| 3 hours: Abdominal pain | 1 | 1 | 1 | 0 | 0 | 1 |
| 3 hours: Diarrhoea | 0 | 0 | 0 | 0 | 0 | 0 |
| 3 hours: Vomiting | 0 | 0 | 0 | 0 | 0 | 0 |
| 24 hours: Abdominal pain | 3 | 2 | 0 | 1 | 2 | 0 |
| 24 hours: Diarrhoea | 1 | 0 | 0 | 0 | 4 | 0 |
| 24 hours: Vomiting | 0 | 0 | 0 | 0 | 2 | 0 |
| 14-21 days: Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 |
| 14-21 days: Diarrhoea | 0 | 0 | 0 | 0 | 0 | 0 |
| 14-21 days: Vomiting | 0 | 0 | 0 | 0 | 0 | 0 |
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
Collected over 2-3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Ivermectin ODT Placebo & Albendazole | 0/43 (0%) | 0/43 (0%) | 4/43 (9.3%) |
| Arm B: Ivermectin ODT 100 µg/kg & Albendazole | 0/44 (0%) | 0/44 (0%) | 3/44 (6.8%) |
| Arm C: Ivermectin ODT 200 µg/kg & Albendazole | 0/42 (0%) | 0/42 (0%) | 1/42 (2.4%) |
| Arm D: Ivermectin ODT 300 µg/kg & Albendazole | 0/44 (0%) | 0/44 (0%) | 1/44 (2.3%) |
| Arm E: Ivermectin ODT 400 µg/kg & Albendazole | 0/44 (0%) | 0/44 (0%) | 7/44 (15.9%) |
| Arm F: Ivermectin Standard Tablets & Albendazole | 0/43 (0%) | 0/43 (0%) | 1/43 (2.3%) |
| Event | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole |
|---|---|---|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/43 | 0/44 | 0/42 | 0/44 | 4/44 | 0/43 |
| Abdominal painGastrointestinal disorders | 3/43 | 3/44 | 1/42 | 1/44 | 2/44 | 1/43 |
| VomitingGastrointestinal disorders | 0/43 | 0/44 | 0/42 | 0/44 | 2/44 | 0/43 |
| Age, Continuous(years) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Mean | 3.7 ± 1.1 | 3.6 ± 1.1 | 3.5 ± 1.0 | 3.6 ± 1.0 | 3.5 ± 1.0 | 3.7 ± 1.2 | 3.6 ± 1.1 |
| Sex: Female, Male(Participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Female | 22 | 20 | 24 | 24 | 21 | 26 | 137 |
| Male | 21 | 24 | 18 | 20 | 23 | 17 | 123 |
| Race and Ethnicity Not Collected(Participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Tanzania | 43 | 44 | 42 | 44 | 44 | 43 | 260 |
| Trichuris trichiura infection intensity(Participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Light (<1000 EPG) | 36 | 36 | 34 | 35 | 36 | 34 | 211 |
| Moderate (1000-9999 EPG) | 7 | 8 | 7 | 9 | 8 | 9 | 48 |
| Heavy (>9999 EPG) | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Ascaris lumbricoides co-infection(Participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Count of participants | 10 | 13 | 8 | 7 | 9 | 9 | 56 |
| Hookworm co-infection(Participants) | Arm A: Ivermectin ODT Placebo & Albendazole | Arm B: Ivermectin ODT 100 µg/kg & Albendazole | Arm C: Ivermectin ODT 200 µg/kg & Albendazole | Arm D: Ivermectin ODT 300 µg/kg & Albendazole | Arm E: Ivermectin ODT 400 µg/kg & Albendazole | Arm F: Ivermectin Standard Tablets & Albendazole | Total |
|---|---|---|---|---|---|---|---|
| Count of participants | 8 | 11 | 8 | 10 | 8 | 7 | 52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2024 to primary completion in Aug 2024, 2 months.
Results were first posted in Sep 2025, 1 year 1 month after primary completion.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ivermectin
Jennifer Keiser