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11 February 2012
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| [ Print-friendly version ] |
| Sulfadoxine-pyrimethamine (SP) Combinations Study |
| ISRCTN | ISRCTN22075368 |
| ClinicalTrials.gov identifier | |
| Public title | Sulfadoxine-pyrimethamine (SP) Combinations Study |
| Scientific title | Evaluating strategies to delay the emergence of resistance to antimalarial drugs |
| Acronym | SP Combinations Study |
| Serial number at source | 066681 |
| Study hypothesis |
Compared to sulfadoxine-pyrimethamine monotherapy, the addition of chloroquine or amodiaquine or artesunate results in:
1. Improved clinical and parasitological outcomes at 14, 28 and 42 days 2. Decreased selection of resistance mutations 3. Clinical failures that cannot be explained by the parasite genotype have a pharmacokinetic basis |
| Lay summary | |
| Ethics approval |
Added 22/04/2009:
1. Liverpool School of Tropical Medicine, Research Ethics Commitee gave approval on the 2nd March 2002 (ref: 01.72) 2. University of Malawi, College of Medicine Research Ethics Committee gave approval on the 5th August 2002 (ref: P.01/02/140) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Malawi |
| Disease/condition/study domain | Uncomplicated Malaria |
| Participants - inclusion criteria |
1. Age more than or equal to 12 and less than 60 months, either sex
2. Weight more than or equal to 6 kg 3. Pure (on microscopic grounds) P. falciparum parasitaemia of 2000 to 200,000 ul 4. Written consent has been obtained from the parent or legal guardian |
| Participants - exclusion criteria |
1. Severe Malaria
2. Antimalarials in previous week 3. Other comcomitant infection at time of presentation 4. Allergy to sulphonamides 5. Involvement in the study in the previous 12 months |
| Anticipated start date | 01/09/2003 |
| Anticipated end date | 15/03/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 450 - recruitment ends on the 1st February 2006 |
| Interventions |
Four armed, blinded, randomised trial comparing:
1. SP (single oral dose) and placebo 2. SP (single oral dose) and chloroquine (once daily for 3 days) 3. SP (single oral dose) and amodiaquine (once daily for 3 days) 4. SP (single oral dose) and artesunate (once daily for 3 days) Total duration of follow up in study was 42 days for all participants. |
| Primary outcome measure(s) |
1. World Health Organization (WHO) treatment response endpoints on days 14, 28 and 42
2. Selection of Dihydrofolate Reductase (DHFR) and Dihydropteroate Synthetase (DHPS) resistance associated genotypes 3. Fever clearance time 4. Parasite clearance time 5. Change in Haemoglobin between day zero to 14 6. Gametocyte prevalence on day seven or 14 7. Adverse events clinical and laboratory |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 066681) |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/18270569 |
| Contact name | Dr David Bell |
| Address |
Wellcome Trust Tropical Centre
Block E, Royal Infirmary Complex University of Liverpool 70 Pembroke Place |
| City/town | Liverpool |
| Zip/Postcode | L69 3GF |
| Country | United Kingdom |
| Tel | +44 (0)151 794 4221 |
| Fax | +44 (0)151 794 4222 |
| belldavidj@gmail.com | |
| Sponsor | University of Liverpool (UK) |
| Address |
Research Support
Senate House Abercromby Square |
| City/town | Liverpool |
| Zip/Postcode | L69 3BX |
| Country | United Kingdom |
| Sponsor website: | http://www.liv.ac.uk/ |
| Date applied | 06/04/2005 |
| Last edited | 22/04/2009 |
| Date ISRCTN assigned | 22/07/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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