Status:
COMPLETED
Longitudinal Antimalarial Combinations in Uganda
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
1-10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare different ways of treating uncomplicated malaria in a group of Ugandan children. The study will be divided into 2 parts. Part 1 of the study will consist of 600...
Detailed Description
Malaria is one of the most important infectious diseases worldwide. New therapies are needed, and it is generally agreed that combination therapy for uncomplicated malaria offers the best opportunity ...
Eligibility Criteria
Inclusion
- Phase I
- Age 1 to 10 years.
- Agreement to come to the study clinic for any febrile episode or other illness.
- Agreement to avoid medications administered outside the study.
- Willingness of parents or guardians to provide informed consent.
- Phase II
- Child and Guardian/Parent belong to household currently enrolled in the study.
- Age 1 to 10 years.
- Agreement to come to the study clinic for any febrile episode or other illness.
- Agreement to avoid medications administered outside the study.
- Willingness of parents or guardians to provide informed consent.
Exclusion
- Phase I
- History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care (e.g. AIDS, sickle cell disease, malignancy).
- Intention to move from Kampala during the follow-up period.
- History (obtained from the parent/guardian) of serious side effects to study medications or sulfa drugs.
- Weight \< 10 kg
- Severe malnutrition defined as weight-for-height or height-for-age Z-score \<-3.
- Homozygous hemoglobin SS (sickle cell) result by hemoglobin electrophoresis.
- Life-threatening screening laboratory value in the absence of malaria:
- Absolute neutrophil count: \< 250/mm\^3
- Hemoglobin: \< 5.0 g/dL
- Platelet count: \< 25,000/mm\^3
- Creatinine: \< 2 years: \> 1.5 mg/dL, greater than or equal to 2 years: \> 2.0 mg/dL
- ALT: \> 15.0 x ULN
- Bilirubin: \> 7.5 x ULN Phase II
- History of any known serious chronic disease requiring frequent medical attention (e.g. AIDS, sickle cell disease, malignancy)
- Intention to move from Kampala during the follow-up period
- Any history of serious side effects to study medications
- Weight \< 10 kg
- Severe malnutrition
- Life-threatening screening laboratory test result
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
601 Patients enrolled
Trial Details
Trial ID
NCT00123552
Start Date
November 1 2004
End Date
December 1 2008
Last Update
June 9 2020
Active Locations (1)
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1
Assessment Center - Mulago Hospital
Kampala, Uganda