Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Effect of Artemisinin-based Combination Therapies on Urinary Schistosoma Haematobium When Administered for the Treatment of Malaria Co-infection

Conditions
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Schistosomiasis Haematobia

Intervention / Treatment
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* Drug: Artesunate-Pyronaridine
* Drug: Artemether-Lumefantrine
* Drug: Artefenomel-Ferroquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment Written informed consent Exclusion Criteria: Patients treated with PZQ during the previous 6 weeks Known intolerance /allergy to any study drug Pregnancy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: artemisinin-based combination therapies<br>subjects given Artemisinin-based combined therapies according to the study instruction | Drug: Artesunate-Pyronaridine<br>* Subjects received artesunate-pyronaridine according to their body weight once per day for three days.<br>* Other names: Pyramax;Drug: Artemether-Lumefantrine<br>* subjects received artemether-lumefantrine according to their body weight twice per day for three days.<br>* Other names: Coartem;|
| Sham Comparator: non-artemisinin drugs<br>subjects given non artemisinin based combined therapies like describe in the study protocol | Drug: Artefenomel-Ferroquine<br>* Subject received a single dose of artefenomel-ferroquine according to their body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Egg Reduction Rate (ERR) | Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia | Day 28 | 
| Egg Reduction Rate (ERR) | Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure Rate (CR) | CR of ACTs on Schistosoma haematobia | Day 28 | 
| Cure Rate (CR) | CR of ACTs on Schistosoma haematobia | Day 42 |