Please note that as of 26/01/2009 this record has been extensively updated. All updates can be found in the relevant section under the above update date. Please also note that as of 26/01/2009 the trial dates have changed. The inital trial dates were as follows:
Initial anticipated start date: 18/07/2005
Initial anticipated end date: 31/12/2007 (amended to 30/04/2009 in February 2007)
As of 02/02/2010 the Democratic Republic of Congo was added as a country of recruitment.
As of 20/04/2010 this record was updated to include an extended anticipated end date ; the previous anticipated end date was 31/03/2010. At this time, the secondary endpoints were also updated; please see the relevant section for more details of this.
This was the largest ever study in children hospitalized with severe malaria. It sought to determine whether a drug called artesunate was a better treatment than the usual drug quinine. Artesunate had been shown already to be superior in patients (mainly adults) studied in South-East Asia, but uncertainty remained over whether it was better in African children, who bear most of the burden of severe malaria in the world.
Who can participate?
The study was conducted in 11 centers located in 9 countries across Africa during the study period. All children hospitalized could be enrolled provided the doctor suspected severe malaria, their blood test showed malaria, they were over 18 months of age, and their parent or carer agreed.
What does the study involve?
The children were randomly allocated to receive one drug or the other by injection or by a drip. The medical staff were all aware of which treatment was given. The primary outcome of the study was whether or not the child survived to leave hospital. We also checked carefully for complications of the disease or the drug, particularly residual brain damage from cerebral malaria.
What are the possible benefits and risks of participating?
Quinine was the established time-honoured treatment. There were no risks to participating in the study and most children who were eligible were enrolled.
Where is the study run from?
The study was coordinated by the Mahidol Oxford Research Unit in Bangkok, Thailand
When is the study starting and how long is it expected to run for?
The study ran between Oct 3, 2005, and July 14, 2010
Who is funding the study?
The Wellcome Trust
Who is the main contact?
Prof NJ White
nickw@tropmedres.ac
2. The Gambia: The Gambia Government/MRC Laboratories Joint Ethics Committee, 5th October 2005 (ref: L2005.91)
3. Kenya: KEMRI National Ethics Review Committee, 21st October 2005 (ref: KEMRI/RES/7/3/1)
4. Ghana: University of Science and Technology School of Medical Science, Committee on Human Research Publication and Ethics, 23rd January 2006 (ref: CHRPE/01/06)
5. Mozambique: Ministry of Health, Comité Nacional de Bioética para a saùde, 4th June 2007 (ref: IRB 00002657-105/CNBS/07)
6. Tanzania: Ministry of Health, National Institute for Medical Research (NIMR), 20th April 2007 (ref: NIMR/HQ/R.8c/ Vol. 1/22)
7. Uganda: Mbarara University of Science and Technology, Institutional Ethical Review Committee, 22nd August 2007 (ref: Dos 1/6)
8. Nigeria: University of Ilorin Teaching Hospital, Ethical Review Committee, 26th October 2007 (ref: UITH/CAT/189/10/659)
9. Rwanda: Ministry of Health National Ethics Committee, 3rd April 2008 (ref: IRB 00001497 of IORG 0001100)
Added 02/02/2010:
10. Democratic Republic of Congo: Le Comité d’Ethique de l’Ecole de Santé Publique de l’Université de Kinshasa approved on the 24th September 2009 (ref: 050/2009)
All other centres received ethics approval prior to recruiting the first participant.
2. Treating physician considers patient to have severe malaria
2. Patient has a known allergy to quinine or an artemisinin derivative
Current information as of 26/01/2009:
Patients are randomised to treatment with either intravenous (i.v.) or intramuscular (i.m.) artesunate or i.v. or i.m. quinine.
Initial information at time of registration:
In two of the study sites intramuscular artesunate will be compared with intramuscular quinine. In two other study sites the comparison will be between intravenous artesunate and intravenous quinine.
1. Neurological sequelae at day 28 after discharge from the hospital
2. Combined in-hospital mortality and neurological sequelae at day 28 after discharge from the hospital
Initial information at time of registration:
1. Neurological sequelae
2. Recovery times:
2.1. To localise pain
2.2. To speak
2.3. To sit unsupported
2.4. To eat or breast feed, and
2.5. To discharge from hospital
Assessed at discharge.
Wellcome Unit
420/6 Rajvithi Road
Wellington Square