Schistosoma haematobium, urogenital schistosomiasis or bilharzia
Conditions
Interventions
None
Sponsors
Merck Pty Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all the following criteria apply: Age 1. Are 2 to 6 years of age at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Are S. haematobium positive, diagnosis defined as positive egg counts in urine (=1 egg/10 mL urine) according to WHO classification: light (<50 eggs/10 mL of urine) and heavy (=50 eggs/10 mL of urine) infections (WHO, 2002). Weight 3. Have a minimum body weight of 8.0 kg. Sex 4. Are male or female. Informed Consent 5. Parent or guardian/legally authorised representative must give signed informed consent, as indicated in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol. 6. Parent’s/legally acceptable representative’s ability to communicate well with the Investigator and his/her delegate, to understand the protocol requirements and restrictions, and to be willing to have their child comply with the requirements of the entire study, i.e., - To be examined by a study physician at screening and 17 to 21 days after treatment - To provide urine and stool samples at screening, and urine samples at 17 to 21 days after treatment - To provide venous blood samples for laboratory assessments.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions 1. Patients with seizures and/or medical history of seizures and/or other signs of potential central nervous system involvement. 2. Patients with known cysticercosis, or with signs or symptoms (e.g., subcutaneous nodules) suggestive of cysticercosis. 3. Patients with an acute infection or other acute illness within the 7 days prior to study screening. Prior/Concomitant Therapy 4. Treatment with PZQ within the 4 weeks prior to the study screening. 5. Concomitant treatment (within 2 weeks prior to enrollment) with medication that might affect the metabolism of PZQ, such as certain anti-epileptics (e.g., carbamazepine or phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or cimetidine (Biltricide® ). 6. Treatment within the 2 weeks prior to the study screening with anti-malarial medications. Prior/Concurrent Clinical Study Experience 7. Administration of any investigational product within 4 weeks prior to administration of PZQ ODT or anticipated at any time until completion of the End-of-Study visit. Diagnostic Assessments 8. Fever, defined as temperature above 37.5 °C axillary or oral. 9. Debilitating illness such as tuberculosis, malnutrition, etc. 10. Mixed S. haematobium and S. mansoni infections. 11. Findings in the clinical examination and/or laboratory safety examination on the treatment day, that in the opinion of the Investigator constitute a risk or a contraindication for the participation of the child in the study or that could interfere with the study objectives, conduct or evaluation. This includes but is not restricted to bacterial or viral infections, such as dysentery, gastroenteritis, etc. Other Exclusions 12. History of hypersensitivity to PZQ or any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure is defined as no parasite eggs in the urine 17 to 21 days after treatment. Egg counts will be determined by urine examination using the urine filtration technique: Three urine samples (10 mL) will be collected on different days, within a maximum of 5 days, during the screening period (Day -28 to Day -1) and will be averaged to determine the baseline egg count /10mL. Three additional urine samples will be collected 17 to 21 days after single dosing and averaged to determine the post-treatment egg count /10mL. The urine samples will be filtered through a filter mesh; the mesh will then be examined under the microscope for S. haematobium egg count. | — |
Secondary
| Measure | Time frame |
|---|---|
| • For each subject, ERR (%) will be calculated based on the mean egg count per 10 mL of three urine samples, measured pre- and post-treatment. The mean egg counts can be calculated as geometric mean (primary) and arithmetic mean (secondary). • At group level, ERR point estimate will be the average of individual ERR. The corresponding confidence interval (CI) will be determined by percentile method based on resampling, i.e., bootstrapping. ;Safety and tolerability assessments: - Occurrence, nature, severity and outcome of adverse events - Occurrence of Adverse Drug Reactions per treatment group - Changes in laboratory safety parameters and vital signs (body temperature, blood pressure and pulse rate) ;Reaction to PZQ-ODT administration (e.g., spitting, crying) to assess tolerability as assessed by nurse/site staff for all children enrolled in the study | — |
Countries
Zimbabwe
Contacts
Public ContactDeon Bezuidenhout
Associate Director and Praziquantel Global CRM Lead Regional Clinical Research Manager Merck Biopharma Global Clinical Operations
Outcome results
None listed