Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in Afric… (NCT03893097) | Clinical Trial Compass
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 range
6 Years – 14 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared artesunate-mefloquine to the standard praziquantel treatment for schistosomiasis — now that the study is completed, has the results data been published, and what did it show about whether artesunate-mefloquine worked as well or better than praziquantel?
2Since this was a Phase 3 trial, there should be a reasonable amount of safety data available — can you walk me through what side effects or safety events were reported with artesunate-mefloquine compared to the standard praziquantel regimen, so we can weigh the risks?
3The trial tested a single course of artesunate-mefloquine specifically in African children with Schistosoma haematobium or Schistosoma mansoni — given those findings, do you think this combination treatment would be relevant or appropriate to consider in our situation, or is standard praziquantel still the better path?
4Because the trial is now completed rather than still enrolling, participation isn't possible — but based on what the results showed, is there any reason to think artesunate-mefloquine might eventually become a recommended treatment option, and should that influence the treatment decisions we make right now?
5Mefloquine is known to have neurological side effects in some people — did the trial results raise any specific safety concerns about the artesunate-mefloquine combination that you think are important for us to understand before settling on a treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen