Contact information
Type
Scientific
Primary contact
Dr Frank Smithuis
ORCID ID
Contact details
Thanlwin Road 62 A
Yangon
-
Myanmar
+95 1 534679
msfh_yangon@mptmail.net.mm
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Non-inferiority of efficacy and effectiveness of dihydroartemisinin-piperaquine compared to mefloquine-artesunate for the treatment of uncomplicated falciparum malaria in adults and children in western Myanmar.
Ethics approval
Approved by Doctors Without Borders (Medecins sans Frontieres [MSF]) Ethical Review Board on 05/12/2003
Study design
An open randomised comparison
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Falciparum malaria
Intervention
Comparison of two different treatment regimes: dihydroartemisinin-piperaquine and mefloquine-artesunate. Both treatment regimes were given observed or not observed; total of four study groups.
Intervention type
Drug
Phase
Not Specified
Drug names
Dihydroartemisinin-piperaquine and artesunate-mefloquine
Primary outcome measure
Polymerase chain reaction (PCR) adjusted parasitological failure rates by day 42
Secondary outcome measures
1. Vivax appearances
2. Gametocytaemia (person gametocyte weeks between day 0 and 42)
3. Whole blood piperaquine levels at day 7
4. Adverse effects
Overall trial start date
08/12/2003
Overall trial end date
30/03/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with fever (axillary temperature >37.5°C), or a history of fever within 48 hours
2. Confirmed falciparum malaria (mixed infection P. falciparum with P. vivax and/or P. malariae were included), with more than 500 but less than 100,000 asexual parasites per ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
640
Participant exclusion criteria
1. Signs of severe and complicated malaria
2. Children below one-year-old
3. Pregnant women
4. Patients with a history of taking mefloquine during the previous two months
5. Patients taken any other antimalarial drugs in the previous 48 hours
6. Patients with a history of psychiatric diseases
Recruitment start date
08/12/2003
Recruitment end date
30/03/2004
Locations
Countries of recruitment
Myanmar
Trial participating centre
Thanlwin Road 62 A
Yangon
-
Myanmar
Sponsor information
Organisation
Doctors Without Borders (Medecins sans Frontieres [MSF]) (The Netherlands)
Sponsor details
Plantage Middenlaan 14
Amsterdam
1018DD
Netherlands
+31 (0)20 5208700
info@amsterdam.msf.org
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Internally funded by Doctors Without Borders (Artsen zonder Grenzen MSF) (Holland)
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
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16798391
Publication citations
-
Results
Smithuis F, Kyaw MK, Phe O, Aye KZ, Htet L, Barends M, Lindegardh N, Singtoroj T, Ashley E, Lwin S, Stepniewska K, White NJ, Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison., Lancet, 2006, 367, 9528, 2075-2085, doi: 10.1016/S0140-6736(06)68931-9.