Infection with Schistosoma spp. Infections and Infestations Schistosomiasis [bilharziasis]
Conditions
Interventions
Drug administration, namely:
1. Praziquantel (1 x 40 mg/kg)
2. Mefloquine (1 x 25 mg/kg) plus praziquantel (1 x 40 mg/kg) on the next day
3. Mefloquine-artesunate combination (300/750 mg in three divi
Sponsors
Swiss Tropical and Public Health Institute (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (male and female school children older than 8 years) infected with Schistosoma mansoni and S. haematobium, as assessed by the presence of eggs in the urine or stool 2. Weight of patient greater than 25 kg 3. Able and willing to be examined by a study physician at the beginning of the study and at the end of study (3 weeks post-treatment and 2 - 3 months post-treatment) 4. Able and willing to provide multiple stool and urine samples at the beginning and end of study 5. Absence of major systemic illnesses, as assessed by the medical doctor, upon initial clinical assessment 6. Absence of psychiatric and neurological disorders 7. No known or reported hypersensitivity to mefloquine, praziquantel and/or artesunate 8. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease 9. Signed written informed consent sheet 10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a pregnancy test, upon initial clinical assessment
Exclusion criteria
Exclusion criteria: 1. Pregnancy first trimester 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease 4. Known or reported psychiatric or neurological disorders 5. Use of antimalarial or anthelminthic drug within the past month 6. Attending other clinical trials during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate and egg reduction rate, measured at 21 - 28 days and 2 - 3 months post-treatment by multiple stool and urine sampling (Kato Katz method, urine filtration and ether concentration technique) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events. Patients will be monitored for 3 hours post-treatment and once daily during treatment and for 3 days after the last dose. Details of adverse events will recorded by the study physician during the trial, including variables describing their incidence, onset, cessaton, duration, intensity, frequency, seriousnes and causality. | — |
Countries
Cote d'Ivoire
Outcome results
None listed