An International Observational Study of Adults With Acute Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Infectious Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Brazil, Côte d’Ivoire +14
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other No intervention
This is an observational study
Primary outcome measures
- Day 28 Mortality [Time frame: Day 28]
- Days to recovery scale (DRS) [Time frame: Day 28]
- Time to Sustained Recovery [Time frame: Day 28]
- Ordinal outcome for clinical improvement - Day 7 [Time frame: Day 7]
- Organ support free days [Time frame: Day 28]
- The Sequential Organ Failure Assessment (SOFA) score - Day 28 [Time frame: Day 28]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 20 centers
- Banner University Medical Center Tucson — Tucson
- Stanford University Hospital & Clinics (Site 203-003) — Palo Alto
- UCSF Medical Center (Site 203-001) — San Francisco
- Orlando VA Medical Center (074-032) — Orlando
- University of Illinois at Chicago (Site 008-012) — Chicago
- Lutheran Medical Group — Fort Wayne
- University of Kansas Medical Center (Site 080-044) — Kansas City
- University of Minnesota — Minneapolis
- … and 12 more centers
Australia · 8 centers
- Royal Prince Alfred Hospital (612-056) — Camperdown
- St. Vincent's Hospital (612-002) — Sydney
- Westmead Hospital (Site 612-058) — Westmead
- Royal Brisbane and Women's Hospital (Site 612-055) — Brisbane
- Monash Health (612-009) — Clayton
- Austin Health (Site 612-020) — Heidelberg
- The Alfred Hospital (Site 612-017) — Melbourne
- The Royal Melbourne Hospital (612-025) — Parkville
Argentina · 2 centers
- Instituto Medico Platense (611-025) — La Plata
- Hospital General de Agudos JM Ramos Mejia (Site 611-001) — Buenos Aires
France · 2 centers
- Hospices Civiles de Lyon (631-033) — Lyon
- Hospital St Louis (631-019) — Paris
Greece · 2 centers
- Evangelismos General Hospital (Site 635-020) — Athens
- 3rd Dept of Medicine, Medical School (Site 635-022) — Athens
Japan · 2 centers
- Fujita Health University Hospital — Toyoake
- Japan Institute for Health Security — Tokyo
Peru · 2 centers
- Hospital Nacional Guillermo Almenara Irigoyen (Site 651-003) — Lima
- Instituto Nacional de Entermadades Neoplasicas (Site 651-012 — Lima
South Korea · 2 centers
- Seoul National University Bundang Hospital — Seongnam-si
- Seoul St. Mary's Hospital — Seoul
Uganda · 2 centers
- MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601) — Entebbe
- Lira Regional Referral Hospital (Site 634-605) — Lira
Brazil · 1 center
- Associaco Beneficente Siria - HCor (649-203) — São Paulo
Côte d’Ivoire · 1 center
- CERMIPA (Site 403-001) — Abidjan
Denmark · 1 center
- Rigshospitalet, CHIP (625-006) — Copenhagen
Germany · 1 center
- Klinik I fur Innere Medizin der Universitat zu Koln (622-008) — Cologne
Mexico · 1 center
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (653-001) — Mexico City
Singapore · 1 center
- Tan Tock Seng Hospital — Singapore
Spain · 1 center
- Hospital Universitari Germans Trias i Pujol (Site 626-003) — Badalona
Thailand · 1 center
- Chulalongkorn University and The HIV-NAT (Site 613-001) — Bangkok
Ukraine · 1 center
- Central City Clinical Hospital of Ivano-Frankivsk City Council (627-302) — Ivano-Frankivsk
United Kingdom · 1 center
- Royal Free Hospital (Site 634-006) — London
Identifiers
NCT: NCT07069400 · STRIVE 002