A Phase 3 interventional study of Moxidectin 2 mg Oral Tablet and Albendazole 400 mg Oral Tablet in Trichuriasis, Ascariasis and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Tanzania. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Jennifer Keiser · Phase 3, Interventional, and 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.
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.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 224 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.
Counted across the registry records on this site, refreshed daily.
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.
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
Drug: Moxidectin 2 mg Oral Tablet · Drug: Albendazole 400 mg Oral Tablet
Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Drug: Albendazole 400 mg Oral Tablet · Drug: Placebo Moxidectin
Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Drug: Placebo Moxidectin · Drug: Placebo Albendazole
Tablets of 2 mg moxidectin
Tablets of 400 mg albendazole
Also known as: Zentel®
Placebo tablets for moxidectin
Placebo tablets for albendazole
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 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.
Time frame: 0 to 24 hours post-treatment
| Milestone | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Started | 114 | 74 | 36 |
| Completed | 111 | 68 | 34 |
| Not completed | 3 | 6 | 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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Cure Rate (CR) Against T. Trichiura | 69.4 (59.9 to 77.8) | 16.2 (8.4 to 27.1) | 11.8 (3.3 to 27.5) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) | 99.1 (98.6 to 99.5) | 64.4 (42.9 to 78.3) | 14.6 (-28.3 to 46.5) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) | 91.1 (82.5 to 96.0) | -12.9 (-121.5 to 51.5) | -123.9 (-196.9 to -11.0) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Cure Rate (CR) Against A. Lumbricoides | 97.2 (85.5 to 99.9) | 100.0 (79.4 to 100.0) | 40.0 (12.2 to 73.8) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) | 99.9 (99.9 to 100.0) | 100.0 (100.0 to 100.0) | 85.0 (4.1 to 98.2) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) | 88.2 (52.4 to 100.0) | 100.0 (100.0 to 100.0) | -17.5 (-134.0 to 23.4) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Cure Rate (CR) Against Hookworm | 83.0 (70.2 to 91.9) | 65.4 (44.3 to 82.8) | 7.7 (0.2 to 36.0) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) | 99.3 (98.6 to 99.7) | 97.8 (94.4 to 99.3) | -24.5 (-240.7 to 61.2) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) | 95.9 (90.8 to 98.7) | 87.3 (77.4 to 95.2) | -113.0 (-244.3 to -11.8) |
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: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| 3 hours: Abdominal pain | 4 | 2 | 1 |
| 3 hours: Diarrhoea | 0 | 0 | 1 |
| 3 hours: Nausea | 0 | 0 | 1 |
| 3 hours: Vomiting | 0 | 0 | 1 |
| 3 hours: Dizziness | 0 | 0 | 1 |
| 3 hours: Headache | 2 | 0 | 1 |
| 24 hours: Abdominal pain | 1 | 0 | 1 |
| 24 hours: Diarrhoea | 0 | 0 | 0 |
| 24 hours: Nausea | 0 | 0 | 0 |
| 24 hours: Vomiting | 0 | 0 | 0 |
| 24 hours: Dizziness | 1 | 0 | 0 |
| 24 hours: Headache | 0 | 0 | 0 |
| 14-21 days: Abdominal pain | 0 | 0 | 0 |
| 14-21 days: Diarrhoea | 0 | 0 | 0 |
| 14-21 days: Nausea | 0 | 0 | 0 |
| 14-21 days: Vomiting | 0 | 0 | 0 |
| 14-21 days: Dizziness | 0 | 0 | 0 |
| 14-21 days: Headache | 0 | 0 | 0 |
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.
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: Moxidectin 4/8 mg & Albendazole | 0/114 (0%) | 0/114 (0%) | 10/114 (8.8%) |
| Arm B: Albendazole | 0/74 (0%) | 0/74 (0%) | 3/74 (4.1%) |
| Arm C: Placebo | 0/36 (0%) | 0/36 (0%) | 3/36 (8.3%) |
| Event | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 5/114 | 2/74 | 1/36 |
| DiarrhoeaGastrointestinal disorders | 0/114 | 0/74 | 1/36 |
| NauseaGastrointestinal disorders | 0/114 | 0/74 | 1/36 |
| VomitingGastrointestinal disorders | 0/114 | 0/74 | 1/36 |
| DizzinessNervous system disorders | 1/114 | 0/74 | 1/36 |
| HeadacheNervous system disorders | 2/114 | 0/74 | 1/36 |
| OtherGeneral disorders | 2/114 | 1/74 | 1/36 |
| Age, Continuous(years) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Mean | 8.0 ± 1.2 | 8.0 ± 1.4 | 7.9 ± 1.2 | 8.0 ± 1.3 |
| Sex: Female, Male(Participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Female | 46 | 34 | 15 | 95 |
| Male | 68 | 40 | 21 | 129 |
| Race and Ethnicity Not Collected(Participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Tanzania | 114 | 74 | 36 | 224 |
| Trichuris trichiura infection intensity(Participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Light infection (<1000 EPG) | 86 | 56 | 27 | 169 |
| Moderate infection (1000-9999 EPG) | 27 | 18 | 8 | 53 |
| Heavy infection (>9999 EPG) | 1 | 0 | 1 | 2 |
| Ascaris lumbricoides co-infection(Participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Count of participants | 38 | 18 | 11 | 67 |
| Hookworm co-infection(Participants) | Arm A: Moxidectin 4/8 mg & Albendazole | Arm B: Albendazole | Arm C: Placebo | Total |
|---|---|---|---|---|
| Count of participants | 53 | 27 | 14 | 94 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2024 to primary completion in Aug 2024, 2 months.
Results were first posted in Sep 2025, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
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 drugs tested here: Moxidectin · Albendazole
Jennifer Keiser