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

• Status: Completed
• Trial end date: 2021-03-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Tropical Medicine, Belgium
• Collaborator: Institut de Recherche en Santé, de Surveillance Épidémiologique et de Formation (IRESSEF)
• Treatments: Artesunate; Mefloquine; Praziquantel

Criteria

Inclusion Criteria:

1. Children ≥6 and ≤14 years of age

2. Enrolled in one of the selected primary schools in the region

3. Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)

4. Informed consent from parents/guardians signed

Exclusion Criteria:

1. History of, or ongoing, epilepsy or psychiatric illness (I.e. recent history of depression, generalized anxiety disorder; history of psychosis, schizophrenia or other major psychiatric disorders) or known hypersensitivity to one of the three study drugs

2. Chronic medication for any reason

3. Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement

4. Any febrile illness

5. Exposure to PZQ or ACT within the three previous months.