|
ISRCTN
|
ISRCTN06498763
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Mefloquine and artesunate against schistosomiasis
|
|
Scientific title
|
Mefloquine, artesunate and mefloquine-artesunate in the treatment of Schistosoma mansoni and Schistosoma haematobium infections in Côte d’Ivoire
|
|
Acronym
|
MQAS-Schisto
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Mefloquine and artesunate, administered singly or in combination, show efficacy against Schistosoma mansoni and Schistosoma haematobium in school-aged children in Africa.
|
|
Ethics approval
|
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)
|
|
Study design
|
Open-label randomised trial
|
|
Countries of recruitment
|
Cote d'Ivoire
|
|
Disease/condition/study domain
|
Schistosomiasis (Schistosoma mansoni; Schistosoma haematobium)
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
30/10/2008
|
|
Anticipated end date
|
20/10/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
Total: 120 (study 1: 60; study 2: 60)
|
|
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 mg/kg)
The duration of treatment is, depending on the drug, 1 - 3 days; duration of follow-up is 3 - 5 days.
|
|
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).
|
|
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.
|
|
Sources of funding
|
Mepha Pharma AG (Switzerland)
|
|
Trial website
|
|
|
Publications
|
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20350194
|
|
Contact name
|
Prof
Jennifer
Keiser
|
|
Address
|
Department of Medical Parasitology and Infection Biology
Swiss Tropical Institute
|
|
City/town
|
Basel
|
|
Zip/Postcode
|
4002
|
|
Country
|
Switzerland
|
|
Tel
|
+41 (0)61 284 8218
|
|
Fax
|
+41 (0)61 284 8105
|
|
Email
|
jennifer.keiser@unibas.ch
|
|
Sponsor
|
Swiss Tropical Institute (Switzerland)
|
|
Address
|
c/o Jennifer Keiser
Department of Medical Parasitology and Infection Biology
|
|
City/town
|
Basel
|
|
Zip/Postcode
|
4002
|
|
Country
|
Switzerland
|
|
Tel
|
+41 (0)61 284 8218
|
|
Fax
|
+41 (0)61 284 8105
|
|
Email
|
jennifer.keiser@unibas.ch
|
|
Sponsor website:
|
http://sti.ch
|
|
Date applied
|
15/10/2008
|
|
Last edited
|
16/06/2010
|
|
Date ISRCTN assigned
|
17/10/2008
|
