An International Observational Study of Adults With Acute Infection

NCT07069400 | Recruiting

• 1 other identifier: STRIVE 002
• Study Type: observational
• Target: 1,500
• Locations: 18 countries
• Sites: 48

Brief 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.

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (6)

• Day 28 Mortality

  All-cause mortality

  Day 28

• Days to recovery scale (DRS)

  The Days to Recovery Scale (DRS) is an ordinal ranked outcome that includes the concepts of mortality and time to recovery, with recovery defined as being discharged from the hospital and reaching home for the duration of the follow- up. At the end of the follow-up period, each patient is classified into one of the DRS categories based on vital status, hospitalization status, and duration it took to reach recovery.

  Day 28

• Time to Sustained Recovery

  Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.

  Day 28

• Ordinal outcome for clinical improvement - Day 7

  For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.

  Day 7

• Organ support free days

  the number of days between enrollment and hospital discharge or day 28 that the participant did not receive support for some organ (lungs, kidneys, etc.)

  Day 28

• The Sequential Organ Failure Assessment (SOFA) score - Day 28

  The SOFA score is one of the most widely used scoring systems in critically ill patients and has also been validated in hospitalized patients with suspected infection outside the ICU. This score assesses organ dysfunction across 6 organ systems. To facilitate use of the SOFA score across a broad range of sites, including those in low- and-middle income countries (LMICs), SpO2 may be substituted for PaO2, and the presence of scleral icterus or jaundice may be substituted for serum bilirubin level . Only clinically available data will be used to calculate SOFA scores. Laboratory tests will not be completed by the study to calculate SOFA scores.

  Day 28

Study Arms (1)

Study group

The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled at study sites globally. Study personnel at the enrolling site will confirm eligibility and obtain consent prior to beginning study procedures. Signing of the informed consent document signifies study entry and Study Day 0. The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. All participants will meet the eligibility criteria below. Specific studies executed with this master protocol may narrow the eligibility criteria to a more specific population (that is, a subset of patients who meet the eligibility criteria in this overarching protocol).

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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (48)

Banner University Medical Center Tucson

Tucson, Arizona, 85719, United States

RECRUITING

Stanford University Hospital & Clinics (Site 203-003)

Palo Alto, California, 94305, United States

RECRUITING

UCSF Medical Center (Site 203-001)

San Francisco, California, 94143, United States

RECRUITING

Orlando VA Medical Center (074-032)

Orlando, Florida, 32827, United States

RECRUITING

University of Illinois at Chicago (Site 008-012)

Chicago, Illinois, 60612, United States

RECRUITING

University of Kansas Medical Center (Site 080-044)

Kansas City, Kansas, 66160, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

NOT YET RECRUITING

Mayo Clinic (Site 054-001)

Rochester, Minnesota, 55905, United States

RECRUITING

University of Nebraska Medical Center (Site 080-045)

Omaha, Nebraska, 68198-5400, United States

RECRUITING

New York University Langone Health (301-013)

New York, New York, 10016, United States

RECRUITING

Mount Sinai Medical Center (Site 301-012)

New York, New York, 11234, United States

RECRUITING

Duke University (301-006)

Durham, North Carolina, 27710, United States

RECRUITING

Wake Forest Baptist Health (210-001)

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic Foundation (Site 207-001)

Cleveland, Ohio, 44195, United States

RECRUITING

Vanderbilt University Medical Center (Site 212-001)

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southwestern Medical Center (084-001)

Dallas, Texas, 75390, United States

RECRUITING

Intermountain Medical Center (Site 211-001)

Murray, Utah, 84107, United States

RECRUITING

West Virginia University Medicine (301-023)

Morgantown, West Virginia, 26506, United States

RECRUITING

Instituto Medico Platense (611-025)

La Plata, Buenos Aires, B1900AVG, Argentina

RECRUITING

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

Buenos Aires, C1221ADC, Argentina

RECRUITING

Royal Prince Alfred Hospital (612-056)

Camperdown, New South Wales, 2050, Australia

RECRUITING

St. Vincent's Hospital (612-002)

Sydney, New South Wales, 2010, Australia

RECRUITING

Westmead Hospital (Site 612-058)

Westmead, New South Wales, 2145, Australia

RECRUITING

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

Brisbane, Queensland, 4029, Australia

RECRUITING

Monash Health (612-009)

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Health (Site 612-020)

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital (Site 612-017)

Melbourne, Victoria, 3004, Australia

RECRUITING

The Royal Melbourne Hospital (612-025)

Parkville, Victoria, 3050, Australia

RECRUITING

Associaco Beneficente Siria - HCor (649-203)

São Paulo, São Paulo, 04004-030, Brazil

RECRUITING

CERMIPA (Site 403-001)

Abidjan, Côte d’Ivoire

RECRUITING

Rigshospitalet, CHIP (625-006)

Copenhagen, 2100, Denmark

RECRUITING

Hospices Civiles de Lyon (631-033)

Lyon, 69002, France

RECRUITING

Hospital St Louis (631-019)

Paris, 75010, France

RECRUITING

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

Cologne, 50937, Germany

RECRUITING

Evangelismos General Hospital (Site 635-020)

Athens, Attica, 10676, Greece

RECRUITING

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

Athens, Attica, 11527, Greece

RECRUITING

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Japan Institute for Health Security

Tokyo, 162-8655, Japan

RECRUITING

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

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Tan Tock Seng Hospital

Singapore, 308443, Singapore

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

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

Badalona, Barcelona, 08916, Spain

RECRUITING

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

Bangkok, 10330, 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, 76018, Ukraine

RECRUITING

Royal Free Hospital (Site 634-006)

London, NW3 2QG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, blood, whole blood, nasal swab, urine, sputum, tracheal aspirate, stool or rectal swab, and skin lesion sampling.

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cavan Reilly, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Schoenecker

CONTACT

612-624-9644; webe0376@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: July 16, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

UA (1); DK (1); DE (1); ES (1); ME (1); TH (1); GB (1); CÔ (1); GR (2); AR (2); AU (8); JP (2); UG (2); SG (1); US (18); FR (2); BR (1); KR (2)