Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
06/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ox.ac.uk

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

  1. 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.

Additional files

Editorial Notes