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Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children

NCT03893097 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 726

Last updated 2021-04-05

No results posted yet for this study

Summary

The SchistoSAM study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern Senegal.

The study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (AM) is respectively similar to or higher than that of a standard praziquantel (PZQ) treatment. Secondly, the study will assess if novel DNA- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

Conditions

  • Schistosoma Haematobium
  • Schistosoma Mansoni

Interventions

DRUG

Praziquantel

40 mg/kg at baseline

DRUG

Artesunate + Mefloquine

4mg/kg artesunate and 8 mg/kg mefloquine at baseline (3 consecutive days) and repeated at Week 6 and Week 12

Sponsors & Collaborators

  • Institut de Recherche en Santé, de Surveillance Épidémiologique et de Formation (IRESSEF)

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Moustapha Mbow, MD · IRESSEF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2021-03-04
Completion
2021-03-04

Countries

  • Senegal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03893097 on ClinicalTrials.gov