CompletedPhase 3

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

Senegal726 participantsStarted 2019-10-14

Plain-language 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.

Who can participate

Age range6 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Children ≥6 and ≤14 years of age
✓. Enrolled in one of the selected primary schools in the region
✓. Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)
✓. Informed consent from parents/guardians signed

Exclusion criteria

✕. 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
✕. Chronic medication for any reason
✕. Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement
✕. Any febrile illness
✕. Exposure to PZQ or ACT within the three previous months.

What they're measuring

Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate

Timeframe: Week 4

Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen

Timeframe: Week 4

Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen

Timeframe: Week 4

Trial details

NCT IDNCT03893097

SponsorInstitute of Tropical Medicine, Belgium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-04

View on ClinicalTrials.gov More Schistosoma Haematobium trials

Plain-language summary

Who can participate

Age range6 Years – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Children ≥6 and ≤14 years of age
✓. Enrolled in one of the selected primary schools in the region
✓. Infected with schistosomiasis (i.e. Schistosoma spp. eggs in urine and/or stool)
✓. Informed consent from parents/guardians signed

Exclusion criteria

✕. 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
✕. Chronic medication for any reason
✕. Any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement
✕. Any febrile illness
✕. Exposure to PZQ or ACT within the three previous months.

What they're measuring

Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate

Timeframe: Week 4

Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen

Timeframe: Week 4

Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen

Timeframe: Week 4