Infection with Opisthorchis viverrini Infections and Infestations Other fluke infections
Conditions
Interventions
Drug administration, namely
1. Mefloquine (1x 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
Sponsors
Swiss Tropical and Public Health Insitute (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (male and female schoolchildren older than 8 years) infected with O. viverrini, as assessed by the presence of eggs in the 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) 4. Able and willing to provide multiple stool 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, tribendimidine and/or artesunate 8. No known or reported history of chronic 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 artesunate, artemether, any ACT, mefloquine or praziquantel within the past month 6. Attending other clinical trials during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure rate and egg reduction rate 21-28 Days post treatment by multiple stool sampling (Kato Katz method, Ether concentration technique and PCR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events Patients will be monitored for 3 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
Laos
Outcome results
None listed