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
Randomised comparison of chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic
Acronym
Study hypothesis
Randomised comparison of chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in 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
Malaria
Intervention
A randomised comparison of three oral antimalarial combinations.
1. Chloroquine plus sulfadoxine-pyrimethamine
2. Artesunate plus mefloquine
3. Artemether-lumefantrine
42-day follow-up period.
Intervention type
Drug
Phase
Not Applicable
Drug names
Chloroquine, sulfadoxine-pyrimethamine, artesunate, mefloquine, artemether-lumefantrine
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
14/07/2002
Overall trial end date
17/10/2003
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 5000 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
Mixed
Gender
Both
Target number of participants
330
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
14/07/2002
Recruitment end date
17/10/2003
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
Charity
Funder name
Wellcome Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
United Kingdom
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/15486837
Publication citations
-
Results
Mayxay M, Khanthavong M, Lindegårdh N, Keola S, Barends M, Pongvongsa T, Yapom R, Annerberg A, Phompida S, Phetsouvanh R, White NJ, Newton PN, Randomized comparison of chloroquine plus sulfadoxine-pyrimethamine versus artesunate plus mefloquine versus artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in the Lao People's Democratic Republic., Clin. Infect. Dis., 2004, 39, 8, 1139-1147, doi: 10.1086/424512.