An International Observational Study of Adults With Acute Infection

Recruiting now

Conditions studied: Infectious Disease

In brief

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.

Key facts

Study ID

NCT07069400

Run by

University of Minnesota

People needed

1500

Starts

2025-08-25

Expected to finish

2027-06-08

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 years old
• Admitted to hospital (or in an emergency department with anticipated hospital admission) for the management of a suspected or confirmed acute infectious disease.
• Onset of symptoms of an infectious disease within the past 30 days.
• Informed consent for study participation by the participant or a surrogate decision maker if the participant lacks capacity for consent.

You may not qualify if…

• Current imprisonment (this does not include quarantine for an infectious disease).
• Patient undergoing comfort care measures only such that treatment focuses on end- of-life symptom management over prolongation of life.
• Expected inability or unwillingness to participate in study procedures.
• In the opinion of the investigator, participation in the study is not in the best interest of the patient.

Where it is running

• Banner University Medical Center Tucson — Tucson, Arizona, United States (enrolling)
• UCSF Medical Center (Site 203-001) — San Francisco, California, United States (enrolling)
• Stanford University Hospital & Clinics (Site 203-003) — Palo Alto, California, United States (enrolling)
• University of Illinois at Chicago (Site 008-012) — Chicago, Illinois, United States (enrolling)
• Lutheran Medical Group — Fort Wayne, Indiana, United States (enrolling)
• University of Kansas Medical Center (Site 080-044) — Kansas City, Kansas, United States (enrolling)
• Orlando VA Medical Center (074-032) — Orlando, Florida, United States (enrolling)
• Mayo Clinic (Site 054-001) — Rochester, Minnesota, United States (enrolling)
• University of Nebraska Medical Center (Site 080-045) — Omaha, Nebraska, United States (enrolling)
• New York University Langone Health (301-013) — New York, New York, United States (enrolling)
• Mount Sinai Medical Center (Site 301-012) — New York, New York, United States (enrolling)
• Duke University (301-006) — Durham, North Carolina, United States (enrolling)
• Wake Forest Baptist Health (210-001) — Winston-Salem, North Carolina, United States (enrolling)
• Cleveland Clinic Foundation (Site 207-001) — Cleveland, Ohio, United States (enrolling)
• Vanderbilt University Medical Center (Site 212-001) — Nashville, Tennessee, United States (enrolling)
• UT Southwestern Medical Center (084-001) — Dallas, Texas, United States (enrolling)
• MEDVAMC (Site 074-006) — Houston, Texas, United States (enrolling)
• Intermountain Medical Center (Site 211-001) — Murray, Utah, United States (enrolling)
• West Virginia University Medicine (301-023) — Morgantown, West Virginia, United States (enrolling)
• Instituto Medico Platense (611-025) — La Plata, Buenos Aires, Argentina (enrolling)
• Hospital General de Agudos JM Ramos Mejia (Site 611-001) — Buenos Aires, Argentina (enrolling)
• Royal Prince Alfred Hospital (612-056) — Camperdown, New South Wales, Australia (enrolling)
• St. Vincent's Hospital (612-002) — Sydney, New South Wales, Australia (enrolling)
• Westmead Hospital (Site 612-058) — Westmead, New South Wales, Australia (enrolling)
• Royal Brisbane and Women's Hospital (Site 612-055) — Brisbane, Queensland, Australia (enrolling)

Full record on ClinicalTrials.gov

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