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

ISRCTN ISRCTN75303340
DOI https://doi.org/10.1186/ISRCTN75303340
Secondary identifying numbers 065146
Submission date
22/07/2005
Registration date
22/07/2005
Last edited
06/02/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleRandomised 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 objectivesRandomised 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) studiedMalaria
InterventionA 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Chloroquine, sulfadoxine-pyrimethamine, artesunate, mefloquine, artemether-lumefantrine
Primary outcome measureParasitological and clinical responses to treatment.
Secondary outcome measures1. Parasite and fever clearance times
2. Gametocytaemia
3. Changes in haematocrit following antimalarial treatment
Overall study start date14/07/2002
Completion date17/10/2003

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants330
Key inclusion criteria1. 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 criteria1. 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 enrolment14/07/2002
Date of final enrolment17/10/2003

Locations

Countries of recruitment

  • Lao People's Democratic Republic

Study participating centre

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

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Website http://www.ox.ac.uk
ROR logo "ROR" https://ror.org/052gg0110

Funders

Funder type

Charity

Wellcome Trust
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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