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ISRCTN
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ISRCTN23425032
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ClinicalTrials.gov identifier
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Public title
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Mefloquine, artesunate, mefloquine-artesunate and tribendimidine against opisthorchiasis
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Scientific title
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Mefloquine, artesunate, mefloquine-artesunate and tribendimidine in the treatment of Opisthorchis viverrini infection in Laos
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Acronym
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MQAS-Opi
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Serial number at source
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N/A
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Study hypothesis
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Mefloquine and artesunate, administered singly or in combination, and tribendimidine show efficacy against Opisthorchis viverrini in school-aged children in Africa
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Lay summary
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Ethics approval
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1. Ethics commission of Basel (Ethikkomission beider Basel [EKBB]), Switzerland approved on the 23rd July 2009 (ref: 209/09)
2. Ministry of Health Lao PDR approved on the 3rd February 2010 (ref: 25/2010)
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Study design
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Phase 2 randomised exploratory open label active controlled parallel group trial
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Countries of recruitment
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Laos
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Disease/condition/study domain
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Infection with Opisthorchis viverrini
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2010
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Anticipated end date
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01/05/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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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 days)
4. Praziquantel (3x 25 mg/kg within 1 day)
5. Tribendimidine (1 x 200 mg (below age of 14) or 400 mg (above age of 14)
The duration of treatment is 1-3 days, depending on the drug. Duration of follow up is 3-5 days.
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Primary outcome measure(s)
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Cure rate and egg reduction rate
21-28 Days post treatment by multiple stool sampling (Kato Katz method, Ether concentration technique and PCR)
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Secondary outcome measure(s)
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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.
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Sources of funding
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University of Basel (Switzerland)
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21111681
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Contact name
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Prof
Jennifer
Keiser
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Address
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Department of Medical Parasitology and Infection Biology
Swiss Tropical and Public Health Institute
Socinstr. 57
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City/town
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Basel
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Zip/Postcode
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4051
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Country
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Switzerland
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Sponsor
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Swiss Tropical and Public Health Insitute (Switzerland)
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Address
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Socinstr. 57
4051 Basel
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City/town
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Basel
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Zip/Postcode
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4051
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Country
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Switzerland
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Date applied
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15/02/2010
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Last edited
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16/03/2011
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Date ISRCTN assigned
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16/03/2010
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