Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
11/03/2013
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

Acronym

Study hypothesis

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

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

Uncomplicated falciparum malaria

Intervention

1. Oral Artesunate-Mefloquine (AM)
2. Dihydroartemisinin-piperaquine (Artekin)

Intervention type

Drug

Phase

Not Specified

Drug names

Artesunate, mefloquine, and dihydroartemisinin-piperaquine (Artekin)

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

20/05/2004

Overall trial end date

20/09/2004

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 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

220

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

20/05/2004

Recruitment end date

20/09/2004

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

Research organisation

Funder name

The Western Pacific Regional Office of the World Health Organisation (Philippines)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 065146)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16903879

Publication citations

  1. Results

    Mayxay M, Thongpraseuth V, Khanthavong M, Lindegårdh N, Barends M, Keola S, Pongvongsa T, Phompida S, Phetsouvanh R, Stepniewska K, White NJ, Newton PN, An open, randomized comparison of artesunate plus mefloquine vs. dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in the Lao People's Democratic Republic (Laos)., Trop. Med. Int. Health, 2006, 11, 8, 1157-1165, doi: 10.1111/j.1365-3156.2006.01671.x.

Additional files

Editorial Notes