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NCT07069400Recruiting

An International Observational Study of Adults With Acute Infection

University of Minnesota

Start Date

8/25/2025

Completion Date

6/8/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

No intervention

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Conditions

Infectious Disease

Locations

Banner University Medical Center Tucson

Tucson, Arizona 85719

United States

Stanford University Hospital & Clinics (Site 203-003)

Palo Alto, California 94305

United States

UCSF Medical Center (Site 203-001)

San Francisco, California 94143

United States

Orlando VA Medical Center (074-032)

Orlando, Florida 32827

United States

University of Illinois at Chicago (Site 008-012)

Chicago, Illinois 60612

United States

Lutheran Medical Group

Fort Wayne, Indiana 46804

United States

University of Kansas Medical Center (Site 080-044)

Kansas City, Kansas 66160

United States

University of Minnesota

Minneapolis, Minnesota 55414

United States

Mayo Clinic (Site 054-001)

Rochester, Minnesota 55905

United States

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska 68198-5400

United States

New York University Langone Health (301-013)

New York, New York 10016

United States

Mount Sinai Medical Center (Site 301-012)

New York, New York 11234

United States

Duke University (301-006)

Durham, North Carolina 27710

United States

Wake Forest Baptist Health (210-001)

Winston-Salem, North Carolina 27157

United States

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio 44195

United States

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee 37232

United States

UT Southwestern Medical Center (084-001)

Dallas, Texas 75390

United States

MEDVAMC (Site 074-006)

Houston, Texas 77030-4211

United States

Intermountain Medical Center (Site 211-001)

Murray, Utah 84107

United States

West Virginia University Medicine (301-023)

Morgantown, West Virginia 26506

United States

Instituto Medico Platense (611-025)

La Plata, Buenos Aires B1900AVG

Argentina

Hospital General de Agudos JM Ramos Mejia (Site 611-001)

Buenos Aires, C1221ADC

Argentina

Royal Prince Alfred Hospital (612-056)

Camperdown, New South Wales 2050

Australia

St. Vincent's Hospital (612-002)

Sydney, New South Wales 2010

Australia

Westmead Hospital (Site 612-058)

Westmead, New South Wales 2145

Australia

Royal Brisbane and Women's Hospital (Site 612-055)

Brisbane, Queensland 4029

Australia

Monash Health (612-009)

Clayton, Victoria 3168

Australia

Austin Health (Site 612-020)

Heidelberg, Victoria 3084

Australia

The Alfred Hospital (Site 612-017)

Melbourne, Victoria 3004

Australia

The Royal Melbourne Hospital (612-025)

Parkville, Victoria 3050

Australia

Associaco Beneficente Siria - HCor (649-203)

São Paulo, São Paulo 04004-030

Brazil

CERMIPA (Site 403-001)

Abidjan,

Côte d’Ivoire

Rigshospitalet, CHIP (625-006)

Copenhagen, 2100

Denmark

Hospices Civiles de Lyon (631-033)

Lyon, 69002

France

Hospital St Louis (631-019)

Paris, 75010

France

Klinik I fur Innere Medizin der Universitat zu Koln (622-008)

Cologne, 50937

Germany

Evangelismos General Hospital (Site 635-020)

Athens, Attica 10676

Greece

3rd Dept of Medicine, Medical School (Site 635-022)

Athens, Attica 11527

Greece

Fujita Health University Hospital

Toyoake, Aichi-ken 470-1192

Japan

Japan Institute for Health Security

Tokyo, 162-8655

Japan

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (653-001)

Mexico City, Mexico City 14080

Mexico

Hospital Nacional Guillermo Almenara Irigoyen (Site 651-003)

Lima, 15033

Peru

Instituto Nacional de Entermadades Neoplasicas (Site 651-012

Lima, 15038

Peru

Tan Tock Seng Hospital

Singapore, 308443

Singapore

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do 13620

South Korea

Seoul St. Mary's Hospital

Seoul, 06591

South Korea

Hospital Universitari Germans Trias i Pujol (Site 626-003)

Badalona, Barcelona 08916

Spain

Chulalongkorn University and The HIV-NAT (Site 613-001)

Bangkok, 10330

Thailand

MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601)

Entebbe,

Uganda

Lira Regional Referral Hospital (Site 634-605)

Lira,

Uganda

Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302)

Ivano-Frankivsk, 76018

Ukraine

Royal Free Hospital (Site 634-006)

London, NW3 2QG

United Kingdom