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

Assessment of the safety and efficacy of oral Moxidectin, Synriam®, Synriam®-Praziquantel combination versus Praziquantel in school children infected with Schistosoma haematobium and Schistosoma mansoni

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63657086
Enrollment
240
Registered
2015-07-19
Start date
2015-05-04
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis Infections and Infestations Schistosomiasis

Interventions

This study has four treatment arms - Two stool samples (study 1), three urine samples (study 2) and one blood finger prick sample will be collected if possible on two consecutive days or otherwise wit

Sponsors

Geigy Foundation
Lead Sponsor
European Research Council
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Efficacy: cure and egg reduction rate of S. mansoni and S. haematobium

Secondary

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

Countries

Cote d'Ivoire

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026