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11 February 2012
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| [ Print-friendly version ] |
| Measuring malaria transmission after drug treatment |
| ISRCTN | ISRCTN11805747 |
| ClinicalTrials.gov identifier | |
| Public title | Measuring malaria transmission after drug treatment |
| Scientific title | The impact of anti-malarial treatment upon the development and persistence of Plasmodium falciparum gametocytes in vitro and in vivo |
| Acronym | N/A |
| Serial number at source | 061910 |
| Study hypothesis | That use of artemisinin combination chemotherapy for treating uncomplicated falciparum malaria in children will reduce transmissibility of malaria to mosquitoes, compared to other combinations or to monotherapies. |
| Lay summary | |
| Ethics approval |
1. LSHTM Ethics Committee approved on 5th September 2000 (ref: 708)
2. Joint Gambia Government/MRC Laboratories Ethics Committee gave approval on the 16th August 2000 (ref: SCC/EC 838/798). Approved annually on the 20th September 2001 (ref: SCC/EC 887/844) and the 14th August 2002 (ref: SCC/EC 910). |
| Study design | Randomised controlled trial |
| Countries of recruitment | Gambia |
| Disease/condition/study domain | Malaria |
| Participants - inclusion criteria |
1. Children one to ten years of age (either sex) attending Farafenni Health Centre, The Gambia, from September to December in each of 2000, 2001 and 2002
2. Children with a temperature more than 37.5°C, or a history of fever 3. Blood-film positive for P. falciparum at a density greater than 500 parasites per ml 4. Signed informed consent was obtained |
| Participants - exclusion criteria |
1. An inability to take drugs orally
2. Treatment with antimalarial chemotherapy within the past two weeks 3. Carriage of circulating gametocytes at presentation 4. Any evidence of chronic disease or acute infection other than malaria 5. Domicile outside the study area (approximately 10 km radius) 6. Any signs or symptoms of severe malaria: a. severe anaemia (peripheral blood Packed Cell Volume [PCV] less than 20%) b. hyper-parasitaemia (more than 250,000 per ml peripheral blood) c. respiratory distress (respiratory rate more than 40 with two of the following: nasal flaring, intercostal indrawing, subcostal recession or grunting) d. repeated generalised convulsions (three or more per 24 hours or two witnessed seizures in 24 hours) e. haemoglobinuria (dark red/black urine) f. jaundice g. prostration h. circulatory collapse |
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 31/12/2003 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 600 |
| Interventions | Combination antimalarial therapy versus established monotherapy. Single-blind open-label randomised controlled trial run over three consecutive transmission seasons in Farafenni, The Gambia. |
| Primary outcome measure(s) |
Major endpoints were:
1. Post-treatment gametocyte carriage over 28 days 2. Infectiousness to mosquitoes of children carrying gametocytes seven days after treatment |
| Secondary outcome measure(s) |
Minor endpoints were:
1. Clinical and parasitological drug efficacy over 28 days of follow-up |
| Sources of funding |
1. The Wellcome Trust (UK) (grant ref: 061910)
2. MRC Laboratories (The Gambia) - Scientific Coordinating Committee (Projects: 838, 887 and 910) |
| Trial website | |
| Publications |
Results:
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12518847 2. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12932091 3. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14728607 4. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15388456 5. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18509532 |
| Contact name | Dr Colin Sutherland |
| Address |
London School of Hygiene & Tropical Medicine
Keppel St |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7927 2338 |
| Fax | +44 (0)20 7636 8739 |
| colin.sutherland@lshtm.ac.uk | |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Address |
Research Grants and Contracts Office
Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7827 2678 |
| Fax | +44 (0)20 7927 5636 |
| Penny.Ireland@lshtm.ac.uk | |
| Sponsor website: | http://www.lshtm.ac.uk |
| Date applied | 31/01/2005 |
| Last edited | 26/01/2009 |
| Date ISRCTN assigned | 22/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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