Schistosomiasis (Schistosoma mansoni
Conditions
Interventions
1. Mefloquine (1 x 25 mg/kg)
2. Artesunate (10 mg/kg in three divided doses within 1 day)
3. Mefloquine-artesunate combination (300/750 mg in three divided doses within 3 days)
4. Praziquantel (1 x 40
duration of follow-up is 3 - 5 days.
Sponsors
Swiss Tropical Institute (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Schoolchild (aged 8 - 16 years, either sex) 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) 2. Weight of schoolchild greater than 25 kg 3. Able and willing to be examined by a physician at the beginning of the study and at the end of study (3 weeks post-treatment) 4. Able and willing to provide multiple stool or 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 disorders and epilepsy 7. No known or reported hypersensitivity to mefloquine 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 by parents/legual guardians and child 10. For females aged 12 years and above, not pregnant in the first trimester, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment
Exclusion criteria
Exclusion criteria: 1. Schoolchild who has clinical malaria (i.e. axillary temperature greater than or equal to 37.5°C and parasitaemia, as assessed by thick and thin blood film examination) 2. Pregnancy first trimester 3. Presence of any abnormal medical condition, judged by the study physician 4. History of acute or severe chronic disease, including hepato-splenic schistosomiasis, macrohaematuria and bloody stools 5. Psychiatric disorders and epilepsy 6. Use of artesunate, artemether, any artemisinin-based combination therapy, mefloquine or praziquantel within the past 7 days 7. Attending other clinical trials during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate and egg reduction rate, measured 21 - 28 days post-treatment by multiple stool sampling using the Kato-Katz method (study 1) and multiple urine sampling using standard urine filtration method (study 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients will be monitored for three hours post-treatment and once daily for 5 days. Details of adverse events will be recorded by the study physician during the trial including variables describing their incidence, onset, cessation, duration, intensity, frequency, seriousness and causality. | — |
Countries
Cote d'Ivoire
Outcome results
None listed