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

Centre de Recherche Médicale de Lambaréné

Status and phase: Completed; Phase 2

Conditions: Schistosomiasis Haematobia

Treatments: Drug: Artefenomel-Ferroquine; Drug: Artesunate-Pyronaridine; Drug: Artemether-Lumefantrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04264130

CEI-006/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

artemisinin-based combination therapies

Active Comparator group

Description:

subjects given Artemisinin-based combined therapies according to the study instruction

Treatment:

Drug: Artemether-Lumefantrine

Drug: Artesunate-Pyronaridine

non-artemisinin drugs

Sham Comparator group

Description:

subjects given non artemisinin based combined therapies like describe in the study protocol

Treatment:

Drug: Artefenomel-Ferroquine