A Phase 3 interventional study of Praziquantel and Artesunate + Mefloquine in Schistosoma Haematobium and Schistosoma Mansoni, sponsored by Institute of Tropical Medicine, Belgium. Completed at 1 site in Senegal. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-04-05.
Sponsored by Institute of Tropical Medicine, Belgium · Phase 3, Interventional, and Treatment
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.
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.
For this purpose, 726 school children, aged 6-14 years old and infected with Schistosoma (as demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the following arms:
Trial participants will be regularly followed-up:
21 studies on the registry are indexed under Schistosomiasis haematobia; 2 are open to participants now.
This study's enrollment of 726 is above the median of 200 across 13 interventional studies indexed under Schistosomiasis haematobia.
Browse Schistosomiasis haematobia studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 104 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive one dose of PZQ at baseline at 40 mg/kg.
Drug: Praziquantel
Participants in this arm will receive the Artesunate-Mefloquine (fixed-drug)combination at 4 mg/kg artesunate and 8 mg/kg mefloquine at 3 consecutive days. This will be repeated twice; at week 6 and week 12.
Drug: Artesunate + Mefloquine
40 mg/kg at baseline
Drug pages: Artesunate · Mefloquine
4mg/kg artesunate and 8 mg/kg mefloquine at baseline (3 consecutive days) and repeated at Week 6 and Week 12
Evaluate the efficacy of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen: Parasitological cure rate
Parasitological cure rate, as assessed by microscopy, after administration of PZQ and after one AM course
Time frame: Week 4
Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen
Frequency of drug-related adverse events and serious adverse events
Time frame: Week 4
Number of safety events of a single course of artesunate-mefloquine for the treatment of schistosomiasis, compared to the standard PZQ regimen
Pattern of drug-related adverse events and serious adverse events
Time frame: Week 4
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
Cure rate, as assessed by microscopy, after the second and after the third AM administration
Time frame: Week 48
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.
Frequency of adverse events and serious adverse events up to 4 weeks after the second and third AM administration.
Time frame: Week 16
Determine the egg reduction rate obtained after single and repeated courses of AM compared to the standard PZQ regimen.
Egg reduction rate after administration of PZQ and after each AM course
Time frame: Week 48
Determine the parasitological efficacy of single and repeated courses of AM by Schistosoma species and by infection intensity.
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
Time frame: Week 16
Assess the impact of repeated AM courses on schistosomiasis-related morbidity
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.
Time frame: Week 48
Determine the diagnostic accuracy of novel schistosomiasis antigen- and DNA-based diagnostic assays to monitor antischistosomal treatment response
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).
Time frame: Week 48
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
* 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.
Time frame: Week 48
Monitor the prevalence of Pf molecular markers associated with mefloquine resistance and the potential emergence of reduced artesunate susceptibility
Prevalence and patterns of mutations in the K13 gene (for artemisinin susceptibility) and increased copy number of the Pfmdr1 gene or other relevant mutations (for mefloquine resistance) observed in the molecular surveys Presence and patterns of mutations observed in incident malaria cases.
Time frame: Week 48
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.
Pattern of adverse events and serious adverse events up to 4 weeks after the second and third AM administration.
Time frame: Week 16
Plan to share: Yes — The proposed research will include data from 726 subjects, infected with Schistosomiasis and treated according to protocol in one of two arms. The final dataset will include phenotypic data such as demographics and medical history, results of the different diagnostic tests under investigation, clinical signs and symptoms, echography findings on Schistosomiasis induced morbidity, results of indirect morbidity markers under investigation, presence or absence of Plasmodium falciparum (Pf) and of Pf molecular resistance markers. All the individual participant data and additional supporting information will be deposited, after deidentification, at the IDDO - Schistosomiasis/STHs Data Platform. This is a platform specifically for Schistosomiasis/STHs data and is part of the IDDO project, an international collaboration hosted by the University of Oxford. The repository has data access policies and procedures consistent with ITM data sharing policies.
Supporting information: Study protocol, Informed consent form
Time frame: We anticipate to deposit the individual participant data into the IDDO repository as soon as possible after publication of both findings on treatment efficacy and diagnostic accuracy, but no later than within one year. No end date is established for availability and access to the submitted data.
Access criteria: For the first five years from submission of the data, decisions regarding data access for third parties will be taken by the authors in collaboration with the ITM Data Access Committee (DAC). After five years, all requests for access to the Data from third parties shall automatically be delegated to DAC of IDDO. The IDDO DAC will provide controlled access to third party researchers whose applications for Data held within the IDDO repository are approved by the DAC in accordance with specific Data Access Guidelines. All requests are reviewed for qualifications of the researchers, the design and objectives of the secondary research, analysis plan and publication plan, consistency with ITM data sharing policies, applicable laws and regulations, and required ethics approvals.
Data sharing details ↗ · www.itg.be
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Artesunate · Mefloquine
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