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 |
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DOI | https://doi.org/10.1186/ISRCTN32978789 |
Secondary identifying numbers | 065146 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 11/03/2013
- 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
Scientific
Mahosot Hospital
Microbiology Laboratory
Mahosot Road
Vientiane
PO Box 5
Lao People's Democratic Republic
Phone | +856 (0)21 250752 |
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Mayfong@tropmedres.ac |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Artesunate, mefloquine, and dihydroartemisinin-piperaquine (Artekin) |
Primary outcome measure | 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 study start date | 20/05/2004 |
Completion date | 20/09/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Lao People's Democratic Republic
Study participating centre
Mahosot Hospital
Vientiane
PO Box 5
Lao People's Democratic Republic
PO Box 5
Lao People's Democratic Republic
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
Website | http://www.ox.ac.uk |
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https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
The Western Pacific Regional Office of the World Health Organisation (Philippines)
No information available
The Wellcome Trust (UK) (grant ref: 065146)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/08/2006 | Yes | No |