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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | The study population includes adult patients admitted to a hospital with a suspected or confirmed acute infection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schoenecker | Contact | 612-624-9644 | webe0376@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cavan Reilly, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center Tucson | Recruiting | Tucson | Arizona | 85719 | United States |
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Serum, blood, whole blood, nasal swab, urine, sputum, tracheal aspirate, stool or rectal swab, and skin lesion sampling.
| Day 28 |
| Stanford University Hospital & Clinics (Site 203-003) | Recruiting | Palo Alto | California | 94305 | United States |
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| UCSF Medical Center (Site 203-001) | Recruiting | San Francisco | California | 94143 | United States |
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| Orlando VA Medical Center (074-032) | Recruiting | Orlando | Florida | 32827 | United States |
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| University of Illinois at Chicago (Site 008-012) | Recruiting | Chicago | Illinois | 60612 | United States |
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| University of Kansas Medical Center (Site 080-044) | Recruiting | Kansas City | Kansas | 66160 | United States |
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| University of Minnesota | Not yet recruiting | Minneapolis | Minnesota | 55414 | United States |
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| Mayo Clinic (Site 054-001) | Recruiting | Rochester | Minnesota | 55905 | United States |
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| University of Nebraska Medical Center (Site 080-045) | Recruiting | Omaha | Nebraska | 68198-5400 | United States |
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| New York University Langone Health (301-013) | Recruiting | New York | New York | 10016 | United States |
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| Mount Sinai Medical Center (Site 301-012) | Recruiting | New York | New York | 11234 | United States |
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| Duke University (301-006) | Recruiting | Durham | North Carolina | 27710 | United States |
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| Wake Forest Baptist Health (210-001) | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| Cleveland Clinic Foundation (Site 207-001) | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Vanderbilt University Medical Center (Site 212-001) | Recruiting | Nashville | Tennessee | 37232 | United States |
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| UT Southwestern Medical Center (084-001) | Recruiting | Dallas | Texas | 75390 | United States |
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| MEDVAMC (Site 074-006) | Recruiting | Houston | Texas | 77030-4211 | United States |
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| Intermountain Medical Center (Site 211-001) | Recruiting | Murray | Utah | 84107 | United States |
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| West Virginia University Medicine (301-023) | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| Instituto Medico Platense (611-025) | Recruiting | La Plata | Buenos Aires | B1900AVG | Argentina |
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| Hospital General de Agudos JM Ramos Mejia (Site 611-001) | Recruiting | Buenos Aires | C1221ADC | Argentina |
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| Royal Prince Alfred Hospital (612-056) | Recruiting | Camperdown | New South Wales | 2050 | Australia |
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| St. Vincent's Hospital (612-002) | Recruiting | Sydney | New South Wales | 2010 | Australia |
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| Westmead Hospital (Site 612-058) | Recruiting | Westmead | New South Wales | 2145 | Australia |
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| Royal Brisbane and Women's Hospital (Site 612-055) | Recruiting | Brisbane | Queensland | 4029 | Australia |
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| Monash Health (612-009) | Recruiting | Clayton | Victoria | 3168 | Australia |
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| Austin Health (Site 612-020) | Recruiting | Heidelberg | Victoria | 3084 | Australia |
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| The Alfred Hospital (Site 612-017) | Recruiting | Melbourne | Victoria | 3004 | Australia |
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| The Royal Melbourne Hospital (612-025) | Recruiting | Parkville | Victoria | 3050 | Australia |
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| Associaco Beneficente Siria - HCor (649-203) | Recruiting | São Paulo | São Paulo | 04004-030 | Brazil |
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| CERMIPA (Site 403-001) | Recruiting | Abidjan | Côte d’Ivoire |
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| Rigshospitalet, CHIP (625-006) | Recruiting | Copenhagen | 2100 | Denmark |
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| Hospices Civiles de Lyon (631-033) | Recruiting | Lyon | 69002 | France |
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| Hospital St Louis (631-019) | Recruiting | Paris | 75010 | France |
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| Klinik I fur Innere Medizin der Universitat zu Koln (622-008) | Recruiting | Cologne | 50937 | Germany |
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| Evangelismos General Hospital (Site 635-020) | Recruiting | Athens | Attica | 10676 | Greece |
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| 3rd Dept of Medicine, Medical School (Site 635-022) | Recruiting | Athens | Attica | 11527 | Greece |
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| Fujita Health University Hospital | Recruiting | Toyoake | Aichi-ken | 470-1192 | Japan |
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| Japan Institute for Health Security | Recruiting | Tokyo | 162-8655 | Japan |
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| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (653-001) | Recruiting | Mexico City | Mexico City | 14080 | Mexico |
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| Hospital Nacional Guillermo Almenara Irigoyen (Site 651-003) | Recruiting | Lima | 15033 | Peru |
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| Instituto Nacional de Entermadades Neoplasicas (Site 651-012 | Recruiting | Lima | 15038 | Peru |
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| Tan Tock Seng Hospital | Recruiting | Singapore | 308443 | Singapore |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| Seoul St. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
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| Hospital Universitari Germans Trias i Pujol (Site 626-003) | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| Chulalongkorn University and The HIV-NAT (Site 613-001) | Recruiting | Bangkok | 10330 | Thailand |
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| MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601) | Recruiting | Entebbe | Uganda |
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| Lira Regional Referral Hospital (Site 634-605) | Recruiting | Lira | Uganda |
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| Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302) | Recruiting | Ivano-Frankivsk | 76018 | Ukraine |
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| Royal Free Hospital (Site 634-006) | Recruiting | London | NW3 2QG | United Kingdom |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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