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

Sponsor

Kenya Medical Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01054651

Collaborator

Dafra Pharma (Industry)

212

Enrollment

Location

Arms

Duration (Months)

105.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Schistosoma Mansoni	Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine Drug: Praziquantel	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-label, Randomized Clinical Trial in Kenya to Determine the Effectiveness of Artesunate + Sulfamethoxypyrazine/Pyrimethamine Vs. Praziquantel in the Treatment of S. Mansoni in Children

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine	Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine Other Names: Co-arinate FDC
Active Comparator: Praziquantel	Drug: Praziquantel Other Names: Biltricide

Arm

Intervention/Treatment

Experimental: Artesunate+Sulfamethoxypyrazine/pyrimethamine

Drug: Artesunate+Sulfamethoxypyrazine/pyrimethamine

Other Names:

Co-arinate FDC

Active Comparator: Praziquantel

Drug: Praziquantel

Other Names:

Biltricide

Outcome Measures

Primary Outcome Measures

Compare the cure rate between the two treatment arms [after 28 days]

Secondary Outcome Measures

Compare the proportion of children excreting schistosoma eggs between the two treatment arms [after 28 days]
Compare the amount of eggs produced between the two arms [after 28 days]
Compare the incidence of clinical and biological adverse events [after 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.