Phase 3
N=1,673
Efficacy and Safety of IVM/ALB Co-administration
Trichuriasis
Bottom Line
View on ClinicalTrials.gov: NCT03527732 ↗Enrolled (actual)
1,673
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) — 24; 32; 16; 140 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Albendazole (Drug); Albendazole and Ivermectin (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) |
24; 32; 16; 140; 18; 140 | — |
| SECONDARY Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) After 6 and 12 Months Post Treatment |
31; 154; 4; 49; 48; 154 | — |
| SECONDARY Egg-reduction Rate (ERR) Against T. Trichiura |
64; 70; 69; 99; 57; 98 | — |
| SECONDARY Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured) |
78; 76; 77; 70; 68; 85 | — |
| SECONDARY Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections. |
100; 100; 100; 100; 100; 100 | — |
Summary
This study is a double-blind randomized clinical trial conducted with two settings in Africa and one in Asia, namely Côte d'Ivoire, Pemba (Zanzibar, Tanzania) and Lao PDR. This study aims at providing evidence on the efficacy and safety of co-administered albendazole and ivermectin versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in children and adults (6-60 years).
The efficacy of the treatment and potential extended effects on follow-up prevalence will be determined 14-21 days, 6 months and 12 months post-treatment by collecting another two stool samples. The cure rate will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment.
Eligibility Criteria
Inclusion Criteria
- Written informed consent signed by either the participant him/herself (≥21 years of age) or by parents and/or caregivers for children/adolescents; and written assent by child/adolescent (aged 6-20 years).
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and on three follow-up assessments (approximately 3 weeks, 6 months, and 12 months later).
- Aged ≥6 to <= 60 years for parallel group trial and ≥6 to <=12 years for DF study.
- At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura and infection intensities of at least 100 EPG.
Exclusion Criteria
- No written informed consent by individual/parents and/or caregiver.
- Presence of major systemic illnesses, e.g. severe anemia (below 80 g/l Hb according to WHO [28]), clinical malaria as assessed by a medical doctor (positive Plasmodium RDT and ≥38 °C ear temperature), upon initial clinical assessment.
- History of acute or severe chronic disease (e.g. cancer, diabetes, chronic heart, liver or renal disease).
- Recent use of anthelmintic drug (within past 4 weeks).
- Attending other clinical trials during the study.
- Negative or low egg count (less than 100 EPG or less than 2 out of 4 slides positive) diagnostic result for T. trichiura eggs in the stool.
- Known allergy to study medications (i.e. albendazole and ivermectin).
- Pregnancy or lactating in the 1st week after birth (according to WHO guidelines within LF control programs [29]).
- Currently taking medication with known interaction (e.g. for albendazole: cimetidine, praziquantel and dexamethasone; for ivermectin: warfarin).
Data sourced from ClinicalTrials.gov (NCT03527732). 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.