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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenya Medical Research Institute
• Collaborator: Dafra Pharma
• Treatments: Artemisinins; Artesunate; Praziquantel; Pyrimethamine; Sulfalene

Criteria

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.