Longitudinal Antimalarial Combinations in Uganda

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 children, ages 1-10, living in the Mulago III Parish of Kampala. Approximately 90 children living in the same household as children from the Phase 1 portion of the study will be enrolled in Phase II of this study. Participants in Phase II of the study will receive an insecticide treated net to cover their bed. Over the course of the study, participants will be tested for malaria when they present to the clinic with a fever or illness. Participants that test positive for malaria will be given 1 of 3 possible study drug combinations. Study procedures will include physical exams and blood samples. Children will participate for about 3 years. Protocol 05-0110 is a study related to this protocol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Amodiaquine; Amodiaquine, artesunate drug combination; Antimalarials; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

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 Criteria:

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