A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni

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

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.

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Detailed Description

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Schistosomiasis remains an important parasitic disease in the tropics, including Kenya. In the absence of a vaccine, the major control strategy is the reduction of morbidity by chemotherapy using Praziquantel. Evidence from laboratory studies and field trials continue to show that schistosome worms have developed reduced susceptibility to Praziquantel. These observations indicate the need for research to monitor the trends in efficacy of praziquantel and the need for research to develop novel antischistosomal drugs. Randomized controlled trials have also shown that Artemisinin derivatives (artesunate, artemether) have antischistosomal activity against S. mansoni, S. haematobium and S. japonicum. We propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of 212 school children infected with S.mansoni in Rarieda district in western Kenya. To do this we will screen about 1000 school children by examination of stool for schistosome eggs. Eligible children will be randomized to receive either artesunate plus sulfamethoxypyrazine-pyrimethamine over 3 days or a single dose of Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction.Our study may provide vital information regarding an alternative treatment for S. mansoni infection in children.

Conditions

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Schistosoma Mansoni

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artesunate+Sulfamethoxypyrazine/pyrimethamine

Group Type EXPERIMENTAL

Artesunate+Sulfamethoxypyrazine/pyrimethamine

Intervention Type DRUG

Praziquantel

Group Type ACTIVE_COMPARATOR

Praziquantel

Intervention Type DRUG

Interventions

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Artesunate+Sulfamethoxypyrazine/pyrimethamine

Intervention Type DRUG

Praziquantel

Intervention Type DRUG

Other Intervention Names

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Co-arinate FDC Biltricide

Eligibility Criteria

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Inclusion Criteria

* Aged between 6 and 15 years old
* Study participants appear healthy at enrollment, as assessed by the study clinician
* Suffering from S. mansoni infection, excreting eggs in stool
* Residing in Uyoma area, near Lake Victoria
* Able to receive oral treatment
* Parent/legal guardian gives informed written consent for the child to participate in the study
* Child assent to participate in study

Exclusion Criteria

* Weighing more than 50 kg
* Pregnant or lactating at the time of the study
* Presence of infection with Plasmodium falciparum or other Plasmodium spp.
* Presence of severe illness, such as cerebral cysticercosis
* Signs of severe malnutrition (defined as children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet)
* Hypersensitivity to As, sulfonamides or PZQ.
* Use of another anti-malaria or anti-schistosomal drug during the study, or within 28 days before the administration of treatment.
* Previous participation in this study.

Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes