Phase 2
N=260
Efficacy, Safety and Acceptability of Ivermectin ODT in PSAC
Trichuriasis · Ascariasis · Hookworm Infections
Bottom Line
View on ClinicalTrials.gov: NCT06184399 ↗Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Cure Rate (CR) Against T. Trichiura — 17.5; 50.0; 83.3; 84.6 percentage of participants cured (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ivermectin 1.5 mg ODT (Drug); Ivermectin 3 mg Oral Tablet (Drug); Albendazole 400 mg Oral Tablet (Drug); Placebo Ivermectin ODT (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate (CR) Against T. Trichiura |
17.5; 50.0; 83.3; 84.6; 90.0; 73.8 | — |
| SECONDARY Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR) |
65.5; 97.2; 99.7; 99.7; 99.8; 99.2 | — |
| SECONDARY Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR) |
30.2; 88.3; 98.9; 97.9; 98.3; 79.8 | — |
| SECONDARY Cure Rate (CR) Against A. Lumbricoides |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Cure Rate (CR) Against Hookworm |
100.0; 45.5; 62.5; 70.0; 71.4; 57.1 | — |
| SECONDARY Egg Reduction Rate (ERR) Against Hookworm (Geometric Mean ERR) |
100.0; 93.1; 97.4; 97.9; 98.6; 97.1 | — |
| SECONDARY Egg Reduction Rate (ERR) Against Hookworm (Arithmetic Mean ERR) |
100.0; 85.7; 88.9; 92.8; 92.2; 62.3 | — |
| SECONDARY Number of Participants Reporting Adverse Events (AEs) |
1; 1; 1; 0; 0; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document)
- having given written informed consent signed by parents/caregivers
- being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
- having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
- being able and willing to be examined by a study physician before and after treatment
Exclusion Criteria
- presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <70 g/l)
- history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
- use of anthelminthic drugs during study period
- known allergy to study medication (i.e., ivermectin or albendazole)
- being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
- concurrent participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT06184399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.