A Phase 2 interventional study of Artesunate-Pyronaridine and Artemether-Lumefantrine in Schistosomiasis Haematobia, sponsored by Centre de Recherche Médicale de Lambaréné. Completed at 1 site in Gabon. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Centre de Recherche Médicale de Lambaréné · Phase 2, Interventional, and Treatment
Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.
Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.
21 studies on the registry are indexed under Schistosomiasis haematobia; 2 are open to participants now.
This study's enrollment of 54 is below the median of 200 across 13 interventional studies indexed under Schistosomiasis haematobia.
Browse Schistosomiasis haematobia studies →Centre de Recherche Médicale de Lambaréné is the lead sponsor of 17 studies on the registry; 3 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.
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.
subjects given Artemisinin-based combined therapies according to the study instruction
Drug: Artesunate-Pyronaridine · Drug: Artemether-Lumefantrine
subjects given non artemisinin based combined therapies like describe in the study protocol
Drug: Artefenomel-Ferroquine
Subjects received artesunate-pyronaridine according to their body weight once per day for three days.
Also known as: Pyramax
subjects received artemether-lumefantrine according to their body weight twice per day for three days.
Also known as: Coartem
Subject received a single dose of artefenomel-ferroquine according to their body weight
Egg Reduction Rate (ERR)
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Time frame: Day 28
Egg Reduction Rate (ERR)
Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia
Time frame: Day 42
Cure Rate (CR)
CR of ACTs on Schistosoma haematobia
Time frame: Day 28
Cure Rate (CR)
CR of ACTs on Schistosoma haematobia
Time frame: Day 42
Plan to share: No
Ran from Jul 2018 to primary completion in Dec 2019, 17 months.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Centre de Recherche Médicale de Lambaréné