Randomised placebo controlled trial of intermittent malaria treatment through the Expanded Programme on Immunisation (EPI) to prevent malaria/anaemia in infants (Kenya)
Not Applicable
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN46236868
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
2012 Results article in https://pubmed.ncbi.nlm.nih.gov/22850358/ (added 19/07/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 900
Inclusion Criteria
1. Infants of both gender whose parents or guardians give consent and agree to participate in the study for at least eighteen months
2. Infants who will be presenting to the clinic for their second Diphtheria, Pertussis, Tetanus (DPT) and second Oral Polio Vaccine (OPV) immunisations and are aged less than one
Exclusion Criteria
1. Infants with known hypersensitivity to study drugs
2. Infants with congenital malformations and history of haemolytic anaemia
3. Infants with a history of blood transfusion in the previous week
4. SP treatment in the previous two weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Effectiveness of intermittent malaria treatment of infants with SP (versus placebo) within the Kenya EPI schedule in preventing severe anaemia and malaria<br> 2. Assessment of serological responses to EPI vaccines in children receiving SP versus those receiving placebo for SP<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Determine whether intermittent malaria treatment results in a rebound effect of more episodes of malaria after treatment is stopped<br> 2. Determine whether intermittent malaria treatment results in improved growth of infants<br>