Status:
COMPLETED
Chemopreventive Therapy for Malaria in Ugandan Children
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Malaria
Eligibility:
All Genders
4-5 years
Phase:
PHASE3
Brief Summary
Young African children living in high transmission areas suffer the greatest burden of malaria. In most African countries, such as Uganda, the only current preventive measure against malaria in high t...
Detailed Description
Convenience sampling will be used to enroll a cohort of 600 HIV-uninfected infants between the ages of 4-5 months of age according to the following strata based on the mother's HIV status: 1) 200 HIV-...
Eligibility Criteria
Inclusion
- Age 4 -5 months
- Confirmed HIV status of biological mother
- Negative HIV DNA PCR test at time of enrollment for infants born to HIV-infected mothers
- Infants born to HIV-infected mothers must be breastfeeding
- Residency within 30km of the study clinic
- Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol
- Provision of informed consent by parent/guardian
Exclusion
- History of allergy or sensitivity to TS, SP, or DP
- Active medical problem requiring in-patient evaluation at the time of screening
- Intention of moving more that 30km from the study clinic during the follow-up period
- Chronic medical condition (i.e. malignancy) requiring frequent medical attention
- Living in the same household as a previously enrolled study participant
- QTc interval \> 450 msec
- Other clinically significant ECG abnormalities such as arrhythmia, ischemia, or evidence of heart failure
- Family history of Long QT syndrome
- Current use of drugs that prolong the QT interval
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00948896
Start Date
June 1 2010
End Date
April 1 2014
Last Update
November 24 2015
Active Locations (1)
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1
IDRC Research Clinic -Tororo District Hospital
Tororo, Uganda