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Sponsors and Collaborators: |
University of California, San Francisco ExxonMobil Infectious Diseases Institute of Makerere University, Kampala, Uganda Uganda Malaria Surveillance Project,Kampala,Uganda National Institutes of Health (NIH) Doris Duke Charitable Foundation |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00716599 |
Malaria remains one of the most devastating infectious diseases in the world. Despite the potential for serious adverse outcomes with each episode of malaria, most cases in endemic areas are diagnosed on clinical grounds alone. Even the simple technique of light microscopy, the gold standard for malaria diagnosis, is inaccessible to most individuals in resource-poor malarious areas. New diagnostic methods that are practical for limited health-care settings are urgently needed. Immunochromatographic rapid diagnostic tests (RDTs) for malaria are easy to use, require little infrastructure or expertise, show good accuracy, and are increasingly advocated for routine use in malaria-endemic areas. A major challenge now is to implement RDTs effectively in typical African clinical settings. We plan to evaluate the clinical effectiveness and safety of a training curriculum incorporating RDT use in peripheral government health centers in Uganda. Results from this study will provide evidence for scale-up of RDT implementation in Uganda, as planned by the Uganda Ministry of Health from mid-2008, as well as in other sub-Saharan African countries.
The aim of this study is to evaluate the clinical effectiveness and safety of a basic training program incorporating RDTs, as compared with standard-of-care presumptive treatment, for the management of patients who present with suspected malaria at peripheral health centers in Uganda. Our hypothesis is that training in fever case management and RDT use will allow health center staff to reduce unnecessary antimalarial prescriptions without compromising patient outcomes, compared with the current practice of presumptive antimalarial therapy for all febrile patients.
Condition | Intervention |
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Malaria Fever |
Device: training in use of rapid diagnostic tests (RDTs) for malaria |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effectiveness and Safety of Training in Fever Case Management Incorporating Rapid Diagnostic Tests (RDTs) for Malaria at Peripheral Health Centers in Uganda |
Enrollment: | 14000 |
Study Start Date: | January 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: No Intervention
Health centers continue with standard-of-care empiric case management
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RDT training: Experimental
Health centers randomly selected to receive training and RDTs, for use in routine patient case management
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Device: training in use of rapid diagnostic tests (RDTs) for malaria
training program and introduction of RDTs for use in case management of patients presenting for routine care at government health centers
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Uganda | |
Uganda Malaria Surveillance Project | |
Kampala, Uganda |
Principal Investigator: | Heidi Hopkins, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Heidi Hopkins, MD ) |
Study ID Numbers: | EM-036 |
Study First Received: | July 14, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00716599 |
Health Authority: | United States: Institutional Review Board; Uganda: Research Ethics Committee; Mexico: National Council of Science and Technology |
malaria diagnosis rapid diagnostic test rapid diagnostic tests |
fever case management training fever case management in malaria-endemic areas |
Fever Protozoan Infections Signs and Symptoms Parasitic Diseases Malaria |
Coccidiosis Body Temperature Changes |