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Sulfadoxine-pyrimethamine combinations study

Not Applicable
Completed
Conditions
ncomplicated malaria
Infections and Infestations
Malaria
Registration Number
ISRCTN22075368
Lead Sponsor
niversity of Liverpool (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
450
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. World Health Organization (WHO) treatment response endpoints on days 14, 28 and 42<br>2. Selection of Dihydrofolate Reductase (DHFR) and Dihydropteroate Synthetase (DHPS) resistance associated genotypes<br>3. Fever clearance time<br>4. Parasite clearance time<br>5. Change in haemoglobin between day zero to 14<br>6. Gametocyte prevalence on day seven or 14<br>7. Adverse events clinical and laboratory
Secondary Outcome Measures
NameTimeMethod
o secondary outcome measures
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