Mefloquine and artesunate against schistosomiasis
| ISRCTN | ISRCTN06498763 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06498763 |
| Protocol serial number | N/A |
| Sponsor | Swiss Tropical Institute (Switzerland) |
| Funder | Mepha Pharma AG (Switzerland) |
- Submission date
- 15/10/2008
- Registration date
- 17/10/2008
- Last edited
- 16/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jennifer Keiser
Scientific
Scientific
Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
Basel
4002
Switzerland
| Phone | +41 (0)61 284 8218 |
|---|---|
| jennifer.keiser@unibas.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open-label randomised trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mefloquine, artesunate and mefloquine-artesunate in the treatment of Schistosoma mansoni and Schistosoma haematobium infections in Côte dIvoire |
| Study acronym | MQAS-Schisto |
| Study objectives | Mefloquine and artesunate, administered singly or in combination, show efficacy against Schistosoma mansoni and Schistosoma haematobium in school-aged children in Africa. |
| Ethics approval(s) | 1. Ethikkomission beider Basel EKBB (Switzerland) on the 7th April 2008 (ref: 70/08) 2. Ministère de la Santé d'Higiéne et Publique (Cote d'Ivoire) on the 20th June 2008 (ref: 2868/MSHP) |
| Health condition(s) or problem(s) studied | Schistosomiasis (Schistosoma mansoni; Schistosoma haematobium) |
| Intervention | 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 mg/kg) The duration of treatment is, depending on the drug, 1 - 3 days; duration of follow-up is 3 - 5 days. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Mefloquine, artesunate, praziquantel |
| Primary outcome measure(s) |
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). |
| Key secondary outcome measure(s) |
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. |
| Completion date | 20/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/10/2008 |
| Date of final enrolment | 20/10/2009 |
Locations
Countries of recruitment
- Côte d'Ivoire
- Switzerland
Study participating centre
Department of Medical Parasitology and Infection Biology
Basel
4002
Switzerland
4002
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
