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Mefloquine and artesunate against schistosomiasis
ISRCTN ISRCTN06498763
DOI 10.1186/ISRCTN06498763
ClinicalTrials.gov identifier
EudraCT number
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.
Lay summary
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
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