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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Study group The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection.
  • Other: No intervention
    This is an observational study

Recruiting Locations

University of Kansas Medical Center (Site 080-044)
Kansas City 4273837, Kansas 4273857 66160
Contact:
Hennepin ICC
icsarihenn@strive-network.org

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Rebecca Schoenecker
612-624-9644
webe0376@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.