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Prospective, longitudinal studies of people with acute infections are essential to understand risk factors, clinical manifestations, pathobiology, and management strategies. Observational studies can provide data necessary to select interventions and strategies for testing in clinical trials and to develop key design features of trials. Observational studies can be particularly important for establishing an early knowledge base after emergence of a new pathogen, as illustrated by the recent emergence of influenza A (H1N1), SARS-CoV-2, and Mpox. This observational study protocol describes collection of data and biospecimens from sites across the world for characterizing acute infections in hospitalized patients. The protocol is designed to study respiratory infections, infections outside the respiratory tract, established infectious diseases, and emerging infectious diseases. Data generated in this study will be used to efficiently characterize acute infectious diseases and plan future clinical trials.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Banner University Medical Center Tucson
Tucson, Arizona, United States
Stanford University Hospital & Clinics (Site 203-003)
Palo Alto, California, United States
UCSF Medical Center (Site 203-001)
San Francisco, California, United States
University of Illinois at Chicago (Site 008-012)
Chicago, Illinois, United States
University of Kansas Medical Center (Site 080-044)
Kansas City, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic (Site 054-001)
Rochester, Minnesota, United States
University of Nebraska Medical Center (Site 080-045)
Omaha, Nebraska, United States
New York University Langone Health (301-013)
New York, New York, United States
Mount Sinai Medical Center (Site 301-012)
New York, New York, United States
Start Date
August 25, 2025
Primary Completion Date
June 8, 2027
Completion Date
June 8, 2027
Last Updated
March 16, 2026
1,500
ESTIMATED participants
No intervention
OTHER
Lead Sponsor
University of Minnesota
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07411729