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11 February 2012
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| [ Print-friendly version ] |
| The Africa Quinine versus Artesunate in Severe Malaria Trial |
| ISRCTN | ISRCTN50258054 |
| ClinicalTrials.gov identifier | |
| Public title | The Africa Quinine versus Artesunate in Severe Malaria Trial |
| Scientific title | The AQUAMAT trial: An open label randomised comparison of injectable artesunate and quinine in children with severe falciparum malaria in Africa |
| Acronym | AQUAMAT |
| Serial number at source | 076908 |
| Study hypothesis |
To compare the mortality and significant sequelae of severe falciparum malaria in African children treated with parenteral quinine, to those treated with parenteral artesunate.
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. |
| Lay summary | |
| Ethics approval |
1. UK: Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK), 11th August 2008 (ref: 03402)
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. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Congo, Democratic Republic, Gambia, Ghana, Kenya, Mozambique, Nigeria, Rwanda, Tanzania, Uganda |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. OptiMal malaria rapid test positive, and
2. Treating physician considers patient to have severe malaria |
| Participants - exclusion criteria |
1. Patient has received more than or equal to 24 hours of effective treatment with quinine or an artemisinin derivative, or
2. Patient has a known allergy to quinine or an artemisinin derivative |
| Anticipated start date | 08/10/2005 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 5300 |
| Interventions |
Please note that as of 01/09/10 this trial has reached its target sample size and recruitment has been closed. The trial is now in follow-up.
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. |
| Primary outcome measure(s) | In-hospital mortality |
| Secondary outcome measure(s) |
Current information as of 20/04/2010:
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. |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 076908) |
| Trial website | |
| Publications | |
| Contact name | Prof Nicholas J White |
| Address |
Faculty of Tropical Medicine
Wellcome Unit 420/6 Rajvithi Road |
| City/town | Bangkok |
| Zip/Postcode | 10400 |
| Country | Thailand |
| Tel | +66 (0)2 3549172 |
| Fax | +66 (0)2 3549169 |
| nickw@tropmedres.ac | |
| Sponsor | University of Oxford (UK) |
| Address |
University Offices
Wellington Square |
| City/town | Oxford |
| Zip/Postcode | OX1 2JD |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 22/07/2005 |
| Last edited | 01/09/2010 |
| Date ISRCTN assigned | 22/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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