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

Phase 2

Completed

• Conditions: Schistosomiasis Haematobia
• Interventions: Drug: Artesunate-Pyronaridine; Drug: Artefenomel-Ferroquine; Drug: Artemether-Lumefantrine

• Registration Number: NCT04264130
• Lead Sponsor: Centre de Recherche Médicale de Lambaréné

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-07-31
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-07
• Last Update Submitted: 2020-02-07
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artemisinin-based combination therapies	Artesunate-Pyronaridine	subjects given Artemisinin-based combined therapies according to the study instruction
artemisinin-based combination therapies	Artemether-Lumefantrine	subjects given Artemisinin-based combined therapies according to the study instruction
non-artemisinin drugs	Artefenomel-Ferroquine	subjects given non artemisinin based combined therapies like describe in the study protocol

Primary Outcome Measures

Name	Time	Method
Egg Reduction Rate (ERR)	Day 42	Evaluate ERR conferred by ACTs as treatment of infection with Schistosoma hematobia

Secondary Outcome Measures

Name	Time	Method
Cure Rate (CR)	Day 42	CR of ACTs on Schistosoma haematobia

Trial Locations

Locations (1)

Centre de Recherches Medicales de Lambarene; 🇬🇦 Lambaréné, Gabon