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MAV+ STH Clinical Trial

Efficacy and Safety of Albendazole-based dual and triple combination therapies with Ivermectin and Praziquantel for Soil-Transmitted Helminths among school-aged children in Rwanda: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202606846629607
Enrollment
639
Registered
2026-06-26
Start date
2026-06-08
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soil Transmitted Helminths

Interventions

Sponsors

Team Europe Initiative
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: School age children 5-15 years old, eligible to receive routine MDA according to national guidelines, and enrolled in selected schools in Burera District. Positive for T. Trichiura infection, with or without co-infection with other soil-transmitted helminths (Ascaris lumbricoides or hookworm) and/or schistosomiasis, as confirmed by baseline stool examination. Able to provide assent, with written informed consent obtained from a parent or legal guardian, and assent from the child. Willing to comply with study procedures, sample collection (stool, blood), and follow-up visits. Not currently participating in another clinical trial.

Exclusion criteria

Exclusion criteria: Presence of major illnesses, such as severe anemia and fever upon initial clinical assessment. History of acute or severe chronic disease. Recent use of anthelmintic drug or praziquantel (within past 4 weeks). Known allergy or hypersensitivity to any of the study drugs. Pregnancy and breastfeeding. Children under 5 years, or weighing less than 15 kg, or shorter than 90 cm. Individuals who do not reside in the study area

Design outcomes

Primary

MeasureTime frame
The primary outcome of this trial will be the parasitological cure rate (CR) for Trichuris trichiura, assessed as a binary variable (cured vs. not cured).

Secondary

MeasureTime frame
The secondary outcome will be safety, it will be assessed throughout the study period. All adverse events (AEs) will be monitored and documented with respect to incidence, type, severity, onset, and duration. AEs will be actively captured on Days 1, 2, and 7, as well as participant-initiated reporting between Days 3 and 6

Countries

Rwanda

Contacts

Public ContactParfait Ndizeye

PhD student in the University of Rwanda

parfaitndizeye@gmail.com+250780426164

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026