Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Mefloquine, artesunate, mefloquine-artesunate and tribendimidine in the treatment of Opisthorchis viverrini infection in Laos
Acronym
MQAS-Opi
Study hypothesis
Mefloquine and artesunate, administered singly or in combination, and tribendimidine show efficacy against Opisthorchis viverrini in school-aged children in Africa
Ethics approval
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)
Study design
Phase 2 randomised exploratory open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Infection with Opisthorchis viverrini
Intervention
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.
Intervention type
Drug
Phase
Phase II
Drug names
Artesunate, mefloquine, praziquantel, tribendimidine
Primary outcome measure
Cure rate and egg reduction rate
21-28 Days post treatment by multiple stool sampling (Kato Katz method, Ether concentration technique and PCR)
Secondary outcome measures
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.
Overall trial start date
01/03/2010
Overall trial end date
01/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/03/2010
Recruitment end date
01/05/2010
Locations
Countries of recruitment
Laos
Trial participating centre
Department of Medical Parasitology and Infection Biology
Basel
4051
Switzerland
Funders
Funder type
University/education
Funder name
University of Basel (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21111681
Publication citations
-
Results
Soukhathammavong P, Odermatt P, Sayasone S, Vonghachack Y, Vounatsou P, Hatz C, Akkhavong K, Keiser J, Efficacy and safety of mefloquine, artesunate, mefloquine-artesunate, tribendimidine, and praziquantel in patients with Opisthorchis viverrini: a randomised, exploratory, open-label, phase 2 trial., Lancet Infect Dis, 2011, 11, 2, 110-118, doi: 10.1016/S1473-3099(10)70250-4.