Trial · NCT03893097
Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
NCT03893097, Phase 3, Completed, Institute of Tropical Medicine, Belgium
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children. Trials, record NCT03893097. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03893097
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
- NCT number
- NCT03893097
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 726 participants, actual
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Conditions
- Schistosoma Haematobium, Schistosoma Mansoni
- Interventions
- Praziquantel, Artesunate + Mefloquine
- First posted
- 2019-03-28
- Last updated
- 2021-04-05
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate | Week 4 | Parasitological cure rate, as assessed by microscopy, after administration of PZQ and after one AM course |
| Primary | Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen | Week 4 | Frequency of drug-related adverse events and serious adverse events |
| Primary | Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen | Week 4 | Pattern of drug-related adverse events and serious adverse events |
| Secondary | Evaluate the cumulative efficacy of two additional courses of AM (at 6-week intervals each) for the treatment of schistosomiasis, compared to a single course of AM, and compared to the standard regimen: Cure rate | Week 48 | Cure rate, as assessed by microscopy, after the second and after the third AM administration |
| Secondary | Number of safety events of two additional courses of AM (at 6-week intervals each) for the treatment of schistosomiasis, compared to a single course of AM, and compared to the standard regimen. | Week 16 | Frequency of adverse events and serious adverse events up to 4 weeks after the second and third AM administration. |
| Secondary | Determine the egg reduction rate obtained after single and repeated courses of AM compared to the standard PZQ regimen. | Week 48 | Egg reduction rate after administration of PZQ and after each AM course |
| Secondary | Determine the parasitological efficacy of single and repeated courses of AM by Schistosoma species and by infection intensity. | Week 16 | Cure rate and egg reduction rate by Schistosoma species (S. haematobium and S. mansoni) and by initial Schistosoma infection intensity after PZQ administration and single and repeated courses of AM |
| Secondary | Assess the impact of repeated AM courses on schistosomiasis-related morbidity | Week 48 | Prevalence and severity of general and organ-specific schistosomiasis morbidity (as assessed by clinical evaluation, ultrasound, point-of-care morbidity markers and hemoglobin level) compared to baseline and compared to the control arm. |
| Secondary | Determine the diagnostic accuracy of novel schistosomiasis antigen- and DNA-based diagnostic assays to monitor antischistosomal treatment response | Week 48 | Diagnostic accuracy of the different conventional and novel diagnostic tests (antigen- and DNA-based) at baseline and at defined time points after treatment compared to conventional stool/urine microscopy, and to composite reference standards (any positive test would be considered as infection). |
| Secondary | Determine the effect of repeated AM courses on prevalence of P. falciparum infection as well as on incidence and morbidity of clinical malaria in school-age children with schistosomiasis | Week 48 | * Prevalence of malaria infection, as assessed by molecular testing of dried blood spots. * Incidence of clinical malaria, as assessed by the number of incident malaria cases diagnosed through passive case detection during the study period (by standard malaria rapid tests and molecular diagnostics on dried blood spots). * Frequency and severity of anemia, as assessed by determination of hemoglobin levels. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03893097
GET https://conductscience.org/api/trials/v1/NCT03893097/registered