A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the T… (NCT01054651) | Clinical Trial Compass
CompletedPhase 3
A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni
Kenya212 participantsStarted 2009-10
Plain-language summary
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.
Who can participate
Age range6 Years – 15 Years
SexALL
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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.
What they're measuring
1
Compare the cure rate between the two treatment arms