Condition category
Infections and Infestations
Date applied
15/02/2010
Date assigned
16/03/2010
Last edited
16/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennifer Keiser

ORCID ID

Contact details

Department of Medical Parasitology and Infection Biology
Swiss Tropical and Public Health Institute
Socinstr. 57
Basel
4051
Switzerland

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 measures

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

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

Sponsor information

Organisation

Swiss Tropical and Public Health Insitute (Switzerland)

Sponsor details

Socinstr. 57
4051 Basel
Basel
4051
Switzerland

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21111681

Publication citations

  1. 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.

Additional files

Editorial Notes