Sulfadoxine-pyrimethamine combinations study
Not Applicable
Completed
- Conditions
- ncomplicated malariaInfections and InfestationsMalaria
- 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
Name Time Method 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
Name Time Method o secondary outcome measures