Study Title:
Febrile Illness Surveillance in Northern Tanzania
Sponsor Name: National Institute of Health (NIH)-US
Application Number: TFDA0016/CTR/0008, Date Received: 17/08/2016
Principal Investigator: Dr Venance Maro
Intervention Medicinal Product Status of IMP
Biofire Defence Film Array Instrument unregistered
Primary Disease: febrile illness
Trial Site: Kilimanjaro Christian Medical Centre (KCMC), DUKE University Kilimanjaro AIDS Program Sokoine Road, CCFCC Building, Box 3010 Moshi
Start / Approval Date: 20/10/2017, Status / Approval Remark: Approved
Primary Purpose: To assess the clinical performance and participate in the clinical validation of the Biofie Defence Film Array Global fever panel
Study Phase: Phase III
Study Type: Interventional
Expected Completion Date: 19/10/2020
Target Sample Size: 3000
Recruitment Status: Recruiting
Outcome: Outcome measures; 1) HIV serology and CD4 positiv T-Lymphocyte count 2) Blood cultures 3) Complete blood count and malaria smear 4) Acute and convalescent serology 5) Molecular tests 6) Plasma and cells for HIV and other studies 7) Urine 8)nasopharyngeal speciment 9) Radiographic studies