Malaria Dengue fever, chikungunya fever, Zika virus disease, Leptospirosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Individuals 14 years and older who: - presents with AFI as defined for endemic populations or presents with fever for non-endemic populations - has clinical suspicion of disease caused by at least one of the following: Plasmodium spp, dengue virus, Zika virus, chikunguyna virus, or Leptospira (endemic population) - had a history of residence in or travel to an endemic geographic region within 3 months prior to specimen collection (endemic population)
Exclusion criteria
Exclusion criteria: - Self-reported or known antibiotic or antimalarial medication use (oral or intravenous) within 3 days prior to enrollment (endemic and nonendemic population) - Clinical suspicion of infection caused by any of the following: Plasmodium spp., dengue virus, Zika virus, chikungunya virus, or Leptospira spp. (nonedemic population) - History of residence in or travel to an endemic geographic region as defined by the protocol = three months prior to specimen collection (nonendemic population)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Performance, PPA and NPA, of Xpert Tropical Fever test relative to comparators for the fever-causing agents | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessing the non-determinate rate of the Xpert Tropical Fever Test in whole blood specimens | — |
Countries
Ghana
Contacts
Cepheid Senior Director Clinical Programs