International collaboration to collect information on adults hospitalized with acute infections
An International Observational Study of Adults With Acute Infection
University of Minnesota · NCT07069400
Researchers will collect health information and biological samples from adults hospitalized with acute infections to see how these infections start, progress, and respond to care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 47 sites (Tucson, Arizona and 46 other locations) |
| Trial ID | NCT07069400 on ClinicalTrials.gov |
What this trial studies
This prospective, longitudinal observational protocol enrolls adults admitted to hospital (or in the emergency department with expected admission) for suspected or confirmed acute infectious diseases within 30 days of symptom onset. Participating sites collect clinical data, laboratory results, and biospecimens over time without providing experimental treatments. The design covers respiratory and non-respiratory infections, established infectious diseases, and emerging pathogens. Generated data and samples are intended to characterize disease course and biology and to inform the selection and design of future interventional trials.
Who should consider this trial
Good fit: Adults aged 18 or older who are admitted to hospital (or in the ED with expected admission) for suspected or confirmed acute infection with symptom onset within the past 30 days and who can provide informed consent (or have a surrogate to consent) are appropriate candidates.
Not a fit: Individuals who are currently imprisoned, receiving only comfort/end-of-life care, unable or unwilling to participate, or whom investigators judge participation is not in their best interest are not eligible and would not be expected to benefit.
Why it matters
Potential benefit: If successful, the collected data could speed identification of risk factors and lead to better-targeted treatments and management strategies for future patients with acute infections.
How similar studies have performed: Similar observational efforts were essential for early knowledge about H1N1, SARS-CoV-2 (COVID-19), and Mpox, so this approach has a precedent of providing useful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tucson, Arizona and 46 other locations
- Banner University Medical Center Tucson — Tucson, Arizona, United States (RECRUITING)
- Stanford University Hospital & Clinics (Site 203-003) — Palo Alto, California, United States (RECRUITING)
- UCSF Medical Center (Site 203-001) — San Francisco, California, United States (RECRUITING)
- Orlando VA Medical Center (074-032) — Orlando, Florida, United States (RECRUITING)
- University of Illinois at Chicago (Site 008-012) — Chicago, Illinois, United States (RECRUITING)
- University of Kansas Medical Center (Site 080-044) — Kansas City, Kansas, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
- Mayo Clinic (Site 054-001) — Rochester, Minnesota, United States (RECRUITING)
- University of Nebraska Medical Center (Site 080-045) — Omaha, Nebraska, United States (RECRUITING)
- New York University Langone Health (301-013) — New York, New York, United States (RECRUITING)
- Mount Sinai Medical Center (Site 301-012) — New York, New York, United States (RECRUITING)
- Duke University (301-006) — Durham, North Carolina, United States (RECRUITING)
- Wake Forest Baptist Health (210-001) — Winston-Salem, North Carolina, United States (RECRUITING)
- Cleveland Clinic Foundation (Site 207-001) — Cleveland, Ohio, United States (RECRUITING)
- Vanderbilt University Medical Center (Site 212-001) — Nashville, Tennessee, United States (RECRUITING)
- UT Southwestern Medical Center (084-001) — Dallas, Texas, United States (RECRUITING)
- Intermountain Medical Center (Site 211-001) — Murray, Utah, United States (RECRUITING)
- West Virginia University Medicine (301-023) — Morgantown, West Virginia, United States (RECRUITING)
- Instituto Medico Platense (611-025) — La Plata, Buenos Aires, Argentina (RECRUITING)
- Hospital General de Agudos JM Ramos Mejia (Site 611-001) — Buenos Aires, Argentina (RECRUITING)
- Royal Prince Alfred Hospital (612-056) — Camperdown, New South Wales, Australia (RECRUITING)
- St. Vincent's Hospital (612-002) — Sydney, New South Wales, Australia (RECRUITING)
- Westmead Hospital (Site 612-058) — Westmead, New South Wales, Australia (RECRUITING)
- Royal Brisbane and Women's Hospital (Site 612-055) — Brisbane, Queensland, Australia (RECRUITING)
- Monash Health (612-009) — Clayton, Victoria, Australia (RECRUITING)
- Austin Health (Site 612-020) — Heidelberg, Victoria, Australia (RECRUITING)
- The Alfred Hospital (Site 612-017) — Melbourne, Victoria, Australia (RECRUITING)
- The Royal Melbourne Hospital (612-025) — Parkville, Victoria, Australia (RECRUITING)
- Associaco Beneficente Siria - HCor (649-203) — São Paulo, São Paulo, Brazil (RECRUITING)
- CERMIPA (Site 403-001) — Abidjan, Côte d’Ivoire (RECRUITING)
- Rigshospitalet, CHIP (625-006) — Copenhagen, Denmark (RECRUITING)
- Hospices Civiles de Lyon (631-033) — Lyon, France (RECRUITING)
- Hospital St Louis (631-019) — Paris, France (RECRUITING)
- Klinik I fur Innere Medizin der Universitat zu Koln (622-008) — Cologne, Germany (RECRUITING)
- Evangelismos General Hospital (Site 635-020) — Athens, Attica, Greece (RECRUITING)
- 3rd Dept of Medicine, Medical School (Site 635-022) — Athens, Attica, Greece (RECRUITING)
- Fujita Health University Hospital — Toyoake, Aichi-ken, Japan (RECRUITING)
- Japan Institute for Health Security — Tokyo, Japan (RECRUITING)
- Tan Tock Seng Hospital — Singapore, Singapore (RECRUITING)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
- Seoul St. Mary's Hospital — Seoul, South Korea (RECRUITING)
- Hospital Universitari Germans Trias i Pujol (Site 626-003) — Badalona, Barcelona, Spain (RECRUITING)
- Chulalongkorn University and The HIV-NAT (Site 613-001) — Bangkok, Thailand (RECRUITING)
- MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601) — Entebbe, Uganda (RECRUITING)
- Lira Regional Referral Hospital (Site 634-605) — Lira, Uganda (RECRUITING)
- Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302) — Ivano-Frankivsk, Ukraine (RECRUITING)
- Royal Free Hospital (Site 634-006) — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Cavan Reilly, PhD — University of Minnesota
- Study coordinator: Rebecca Schoenecker
- Email: webe0376@umn.edu
- Phone: 612-624-9644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infectious Disease