Schistosomiasis Infections and Infestations
Conditions
Interventions
Children will be randomized using a computer-generated stratified block randomization code to 4 treatment arms:
Praziquantel (20, 40 and 60 mg/kg) (single oral dose) and placebo
Sponsors
European Research Council
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 and 3 weeks after treatment 3. Able and willing to provide two stool and urine samples at the beginning of the study and 3 weeks after treatment 4. Able and willing to provide 11 finger prick blood samples for PK studies 5. Infected with S. mansoni (study 1) or S. haematobium (study 2), as assessed by the presence of egg(s) in the stool (S. mansoni) or urine (S. haematobium) 6. Absence of major systemic illnesses (e.g. clinical malaria or hepato-splenic schistosomiasis) as assessed by a medical doctor, upon initial clinical assessment 7. 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 liver or renal disease 4. Recent use of anthelminthic drug (within past 4 weeks) 5. Administration of any investigational product or use of any investigational device within 30 days prior to praziquantel administration. Subjects who have used drugs that may affect the pharmacokinetics of praziquantel from 15 days before dosing until the last PK sample, e.g., phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, oral ketoconazole 6. Consumption of substances known to be potent inhibitors or inducers of CYP P450s such as grapefruit juice, grapefruit juice containing products, and herbal remedies or dietary supplements containing St. John?s Wort, in the two weeks before dosing 7. Attending other clinical trials during the study 8. Negative diagnostic result for Schistosoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate (21 days post-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Egg reduction rate (21 days post-treatment) 2. Safety (2h, 24h, 48, 72 h post-treatment) 3. Pharmacokinetic parameters (sampled within 24 hours post-treatment) | — |
Countries
Cote d'Ivoire
Outcome results
None listed