Assessment of the safety and efficacy of different drugs and drug combinations in children infected with schistosomes

Phase 2

Completed

• Conditions: Schistosomiasis; Infections and Infestations

• Registration Number: ISRCTN63657086
• Lead Sponsor: Geigy Foundation

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27636542 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-19
• Study Completion: 2015-10-01
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Written informed consent signed by parents and/or legal guardian, and oral assent by children
2. Able and willing to be examined by a study physician at the beginning of the study
3. Able and willing to provide two stool samples, three urine samples and one finger prick test at baselin and approximately three weeks after treatment (follow-up)
4. Positive for S. mansoni or S. haematobium eggs in the stool and/or in urine
5. Absence of major systemic illnesses (e.g. cancer, diabetes, clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment
6. No known or reported history of chronic illness, e.g. cancer, diabetes, chronic heart, liver or renal disease
7. No anthelminthic or antimalarial treatments within past 4 weeks
8. No known allergy to study medications

Exclusion Criteria

1. No written informed consent by parents and/or legal guardian
2. Presence of any abnormal medical condition, judged by the study physician.
3. History of acute or severe chronic disease such as cancer, diabetes, chronic heart, liver or renal disease
4. Recent use of anthelminthic or antimalarial drugs (within past 4 weeks)
5. Attending other clinical trials during the study
6. Negative diagnostic result for S. mansoni or S. haematobium (absence of helminth eggs in stool/urine)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: cure and egg reduction rate of S. mansoni and S. haematobium

Secondary Outcome Measures

Name	Time	Method
1. Drug safety<br>2. Cure and egg reduction rate against possible co-infections (Ascaris lumbricoides, Trichuris trichiura, hookworm Strongyloides stercoralis)<br>3. To determine the efficacy of Synriam® against malaria infection