Impact of pre-treatment food intake on praziquantel efficacy, side-effects and pharmacokinetics in Schistosoma-infected school-aged children Infections and Infestations
Conditions
Interventions
All children will be screened for Schistosoma infection at baseline using the study diagnostic procedures. Only children with a confirmed Schistosoma infection will be enrolled in the randomized contr
(ii) a high-carbohydrate meal provided prior to treatment
or (iii) a high-fat meal provided prior to treatment. The meals will be administered before praziquantel treatment according to the study protocol.
Randomization will be performed after completion of
Sponsors
Swiss Centre for Scientific Research
Eligibility
Sex/Gender
All
Age
6 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Aged between and including 6 and 15 years 2. A parent/legal guardian provided written informed consent 3. The child provided a signed assent form 4. Agree to comply with study procedures, including providing two stool samples and a urine sample at baseline and during the follow-up survey between 21- and 35-days post-treatment, and venous blood collection and blood micro sampling for dried blood spots (DBS)
Exclusion criteria
Exclusion criteria: 1. Presence or signs of major systemic diseases, i.e., temperature = 38°C, severe anaemia (below 80 g/L, Hb according to WHO , based on baseline clinical examination 2. History of severe acute or chronic illness 3. Recent use of an anthelmintic drug (within the last 4 weeks) 4. Participation in other intervention studies during the same study period 5. Pregnancy and/or a planned pregnancy within the next 3 months 6. A known allergy to investigational products (i.e., praziquantel or study foods) 7. Taking a medication known to be contraindicated for or interacting with praziquantel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug efficacy, cure rate (CR) and egg reduction rate (ERR), measured using microscopy diagnostic methods for urine filtration (urinary schistosomiasis) and Kato-Katz (intestinal schistosomiasis); urine-based antigen testing for point-of-care circulating cathodic antigen (POC-CCA), and an antigen detection assay for circulating anodic antigen (CAA), at 21 days post treatment;Pharmacokinetic parameters, including maximum concentration (Cmax), area under the plasma concentration-time curve from time zero to six hours of quantifiable concentration (AUCt), time to reach maximum concentration (Tmax) and terminal elimination half-life of praziquantel (t1/2), measured using dried blood spots at 0-8 hours post treatment;Treatment-related adverse events measured using observational assessments and questionnaires at 3 and 24 hours post treatment | — |
Countries
Côte d'Ivoire
Contacts
Public ContactJean;Lydia Coulibaly;Trippler
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Outcome results
None listed