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NCT05139524
RVF and Other Emerging Infectious Diseases in East and Central Africa
Conditions: Rift Valley Fever, Hemorrhagic Fevers, Viral
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: Yes
Enrollment: 5000
Sponsor: Washington State University
Location: Virunga Hospital & North Kivu Goma North Kivu
Summary
Rift Valley fever (RVF), a disease transmitted from livestock (cattle, sheep, goats, camels) to humans more commonly occurs in the East and Central Africa (ECA) regions where more than 15 major epidemics affecting more than one country have been reported over the past 50 years. Within the region, there are specific areas, referred to as hotspots, which support RVF virus maintenance via low-level virus circulation between animals, humans, and mosquitoes. Most outbreaks originate from these hotspots. Our goal is to conduct studies in RVF hotspots in four ECA countries, Kenya, Uganda, Tanzania, and Democratic Republic of Congo (DRC) to determine the burden of RVF disease among humans, wildlife and livestock during inter-epidemic periods (IEPs) and discover circulation of undetected infectious diseases. This information is important for use in developing an early warning system and possibly a vaccination strategy. The study will take place in Uganda, Kenya, Tanzania and Democratic Republic of Congo
Eligibility Criteria
Inclusion Criteria for health facility based study:
Category A: A sample of patients presenting to the health facility meeting this inclusion criteria will be enrolled:
• Persons ≥ 10 years of age who are malaria negative AND have undifferentiated acute fever at the time of presentation (≥ 37.5°C) or reported fever in the past 4 weeks.
Category B: A sample of patients presenting to the health facility meeting this inclusion criteria will be enrolled:
• Persons ≥ 10 years of age who are malaria positive AND have undifferentiated acute fever at the time of presentation (≥ 37.5°C) or reported fever in the past 4 weeks.
Category C: All patients at the health facility meeting these criteria will be enrolled in the study
Persons ≥ 10 years of age with:
• Unexplained bleeding with or without fever manifesting as either: Blood in vomitus, Bleeding from the gums, Bleeding from the nose, Bleeding in the eyes (red eyes), Non-menstrual genital bleeding, Bleeding from any other body site OR
• Infectious disease illness of unknown etiology requiring hospitalization. The illness should not be responding to antimalarials and/or antibiotics following 7 days of treatment
Inclusion Criteria for community cross sectional study:
Member of household 2 or more years of age.
Exclusion Criteria:
Those who do not consent or refuse written consent. If a participant is severely ill and has no next of kin to provide consent +/- witness on their behalf.
If a participant is known to have blood clotting disorders, allergies arising from injections, or if a participant has ever fainted during previous injections or blood collection
Source: ClinicalTrials.gov (NCT05139524). StuddyBuddy aggregates publicly available trial information.