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Randomised placebo controlled trial of intermittent malaria treatment through the Expanded Programme on Immunisation (EPI) to prevent malaria/anaemia in infants (Kenya)

Randomised placebo controlled trial of intermittent malaria treatment through the Expanded Programme on Immunisation (EPI) to prevent malaria/anaemia in infants (Kenya)

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46236868
Enrollment
900
Registered
2006-02-01
Start date
1999-12-15
Completion date
Unknown
Last updated
2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

Sulphadoxine-pyrimethamine or placebo given at EPI visits DPT2, DPT3 and measles. Collection of sera to establish impact (if any) upon EPI antigens.

Sponsors

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Effectiveness of intermittent malaria treatment of infants with SP (versus placebo) within the Kenya EPI schedule in preventing severe anaemia and malaria 2. Assessment of serological responses to EPI vaccines in children receiving SP versus those receiving placebo for SP

Secondary

MeasureTime frame
1. Determine whether intermittent malaria treatment results in a rebound effect of more episodes of malaria after treatment is stopped 2. Determine whether intermittent malaria treatment results in improved growth of infants

Countries

Kenya

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026