Clinical and laboratory assessment of antimalarial drug efficacy in Lao PDR: 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

ISRCTN	ISRCTN32978789
DOI	https://doi.org/10.1186/ISRCTN32978789
Protocol serial number	065146
Sponsor	University of Oxford (UK)
Funders	The Western Pacific Regional Office of the World Health Organisation (Philippines), The Wellcome Trust (UK) (grant ref: 065146)

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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Uncomplicated falciparum malaria
Intervention	1. Oral Artesunate-Mefloquine (AM) 2. Dihydroartemisinin-piperaquine (Artekin)
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate, mefloquine, and dihydroartemisinin-piperaquine (Artekin)
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	20/09/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	220
Key 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
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	20/05/2004
Date of final enrolment	20/09/2004

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	01/08/2006		Yes	No