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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Schistosomiasis Haematobia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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artemisinin-based combination therapies

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

Group Type ACTIVE_COMPARATOR

Artesunate-Pyronaridine

Intervention Type DRUG

Subjects received artesunate-pyronaridine according to their body weight once per day for three days.

Artemether-Lumefantrine

Intervention Type DRUG

subjects received artemether-lumefantrine according to their body weight twice per day for three days.

non-artemisinin drugs

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

Group Type SHAM_COMPARATOR

Artefenomel-Ferroquine

Intervention Type DRUG

Subject received a single dose of artefenomel-ferroquine according to their body weight

Interventions

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Artesunate-Pyronaridine

Subjects received artesunate-pyronaridine according to their body weight once per day for three days.

Intervention Type DRUG

Artemether-Lumefantrine

subjects received artemether-lumefantrine according to their body weight twice per day for three days.

Intervention Type DRUG

Artefenomel-Ferroquine

Subject received a single dose of artefenomel-ferroquine according to their body weight

Intervention Type DRUG

Other Intervention Names

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Pyramax Coartem

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