Contact information
Type
Scientific
Primary contact
Dr Mayfong Mayxay
ORCID ID
Contact details
Mahosot Hospital
Microbiology Laboratory
Mahosot Road
Vientiane
PO Box 5
Laos
+856 (0)21 250752
Mayfong@tropmedres.ac
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
065146
Study information
Scientific title
Acronym
Study hypothesis
An open, randomised comparison of artesunate plus mefloquine versus dihydroartemisinin-piperaquine (Artekin) for the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Uncomplicated falciparum malaria
Intervention
1. Oral Artesunate-Mefloquine (AM)
2. Dihydroartemisinin-piperaquine (Artekin)
Intervention type
Drug
Phase
Not Specified
Drug names
Artesunate, mefloquine, and dihydroartemisinin-piperaquine (Artekin)
Primary outcome measures
Parasitological and clinical responses to treatment.
Secondary outcome measures
1. Parasite and fever clearance times
2. Gametocytaemia
3. Changes in haematocrit following antimalarial treatment
Overall trial start date
20/05/2004
Overall trial end date
20/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients or their guardians gave fully informed written consent
2. Had a density of asexual P. falciparum of 1000 to 200,000 per microlitre of blood
3. Were aged more than one year
4. Had an axillary temperature of more than 37.5°C or history of fever in the previous three days
5. Were likely to stay in the hospital until parasite clearance and complete the 42-day follow up period
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
220
Participant exclusion criteria
1. Pregnant or lactating women
2. Patients who took a full course of any antimalarials in the previous three days
3. Patients with signs of severe malaria
4. Those with history of allergy or contraindication to the study drugs
Recruitment start date
20/05/2004
Recruitment end date
20/09/2004
Locations
Countries of recruitment
Laos
Trial participating centre
Mahosot Hospital
Vientiane
PO Box 5
Laos
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
The Western Pacific Regional Office of the World Health Organisation (Philippines)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 065146)
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. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16903879
Publication citations
-
Results
Mayxay M, Thongpraseuth V, Khanthavong M, Lindegårdh N, Barends M, Keola S, Pongvongsa T, Phompida S, Phetsouvanh R, Stepniewska K, White NJ, Newton PN, An open, randomized comparison of artesunate plus mefloquine vs. dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Lao People's Democratic Republic (Laos)., Trop. Med. Int. Health, 2006, 11, 8, 1157-1165, doi: 10.1111/j.1365-3156.2006.01671.x.