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Sulfadoxine-pyrimethamine (SP) Combinations Study
ISRCTN ISRCTN22075368
DOI 10.1186/ISRCTN22075368
ClinicalTrials.gov identifier
EudraCT number
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 Lay summary under review 2
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
  Email 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 09/05/2013
Date ISRCTN assigned 22/07/2005
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