Status:
COMPLETED
Kilimanjaro IPTi Drug Options Trial
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
University of Copenhagen
National Institute for Medical Research, Tanzania
Conditions:
Malaria
Eligibility:
All Genders
2-24 years
Phase:
PHASE2
PHASE3
Brief Summary
Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatmen...
Detailed Description
1. Study design The overall study design is a randomised trial of four treatment regimes in two different transmission settings. The four treatment regimes are as follows: (1) placebo, (2) mefloqu...
Eligibility Criteria
Inclusion
- All infants attending EPI clinics at the 12 study health facilities for first vaccinations. Infants who live within the catchment area of the study health facility and are less than 3 months of age at the time of DPT and Polio 1 vaccination will be eligible for inclusion in the study.
Exclusion
- Infants having any of the following conditions will be excluded: (1) history of allergy to study drugs; (2) history of convulsions; (3) clinical features of severe malnutrition or chronic illness including infants with signs of AIDS \[HIV prevalence in women of reproductive age in the study area was 11.5% in 1999\]39 (4) plans to leave the study area before 12 months of age.(5) weighs \<4.5 kgs (6) caretaker declines to give consent.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
2419 Patients enrolled
Trial Details
Trial ID
NCT00158574
Start Date
January 1 2005
End Date
June 1 2008
Last Update
January 12 2017
Active Locations (1)
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1
Ministry of Health, Korogwe and Same District MCH clinics
Tanga, Tanga and Kilimanjaro, Tanzania