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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mayfong Mayxay
Scientific

Mahosot Hospital
Microbiology Laboratory
Mahosot Road
Vientiane
PO Box 5
Lao People's Democratic Republic

Phone	+856 (0)21 250752
Email	Mayfong@tropmedres.ac

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Chloroquine, sulfadoxine-pyrimethamine, artesunate, mefloquine, artemether-lumefantrine
Primary outcome measure(s)	Parasitological and clinical responses to treatment.
Key secondary outcome measure(s)	1. Parasite and fever clearance times 2. Gametocytaemia 3. Changes in haematocrit following antimalarial treatment
Completion date	17/10/2003

Participant type(s)	Patient
Age group	Mixed
Sex	All
Target sample size at registration	330
Key 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
Key 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
Date of first enrolment	14/07/2002
Date of final enrolment	17/10/2003

Mahosot Hospital

Vientiane
PO Box 5
Lao People's Democratic Republic

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/10/2004		Yes	No