A comparison of the efficacy and effectiveness of dihydroartemisinin-piperaquine and artesunate-mefloquine in the treatment of falciparum malaria

ISRCTN	ISRCTN27914471
DOI	https://doi.org/10.1186/ISRCTN27914471
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Frank Smithuis
Scientific

Thanlwin Road 62 A
Yangon
-
Myanmar

Phone	+95 1 534679
Email	msfh_yangon@mptmail.net.mm

Study design	An open randomised comparison
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Approved by Doctors Without Borders (Medecins sans Frontieres [MSF]) Ethical Review Board on 05/12/2003
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	08/12/2003
Completion date	30/03/2004

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	640
Key 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
Key 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
Date of first enrolment	08/12/2003
Date of final enrolment	30/03/2004

Thanlwin Road 62 A

Yangon
-
Myanmar

Doctors Without Borders (Medecins sans Frontieres [MSF]) (The Netherlands)
Charity

Plantage Middenlaan 14
Amsterdam
1018DD
Netherlands

Phone	+31 (0)20 5208700
Email	info@amsterdam.msf.org
Website	http://www.artsenzondergrenzen.nl
"ROR"	https://ror.org/04237en35

Charity

Internally funded by Doctors Without Borders (Artsen zonder Grenzen MSF) (Holland)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	24/06/2006		Yes	No