An International Observational Study of Adults With Acute Infection

Обзор

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.

Вмешательства

• Другое No intervention
  This is an observational study

Первичные конечные точки

• Day 28 Mortality [Срок оценки: Day 28]
• Days to recovery scale (DRS) [Срок оценки: Day 28]
• Time to Sustained Recovery [Срок оценки: Day 28]
• Ordinal outcome for clinical improvement - Day 7 [Срок оценки: Day 7]
• Organ support free days [Срок оценки: Day 28]
• The Sequential Organ Failure Assessment (SOFA) score - Day 28 [Срок оценки: Day 28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 20 центров

• 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
• … и ещё 12 центров

Австралия · 8 центров

• 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

Аргентина · 2 центра

• Instituto Medico Platense (611-025) — La Plata
• Hospital General de Agudos JM Ramos Mejia (Site 611-001) — Buenos Aires

Франция · 2 центра

• Hospices Civiles de Lyon (631-033) — Lyon
• Hospital St Louis (631-019) — Paris

Греция · 2 центра

• Evangelismos General Hospital (Site 635-020) — Athens
• 3rd Dept of Medicine, Medical School (Site 635-022) — Athens

Япония · 2 центра

• Fujita Health University Hospital — Toyoake
• Japan Institute for Health Security — Tokyo

Перу · 2 центра

• Hospital Nacional Guillermo Almenara Irigoyen (Site 651-003) — Lima
• Instituto Nacional de Entermadades Neoplasicas (Site 651-012 — Lima

South Korea · 2 центра

• Seoul National University Bundang Hospital — Seongnam-si
• Seoul St. Mary's Hospital — Seoul

Uganda · 2 центра

• MRC/UVRI & LSHTM Uganda Research Unit (Site 634-601) — Entebbe
• Lira Regional Referral Hospital (Site 634-605) — Lira

Бразилия · 1 центр

• Associaco Beneficente Siria - HCor (649-203) — São Paulo

Côte d’Ivoire · 1 центр

• CERMIPA (Site 403-001) — Abidjan

Дания · 1 центр

• Rigshospitalet, CHIP (625-006) — Copenhagen

Германия · 1 центр

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

Мексика · 1 центр

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (653-001) — Mexico City

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Испания · 1 центр

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

Таиланд · 1 центр

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

Украина · 1 центр

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

Великобритания · 1 центр

• Royal Free Hospital (Site 634-006) — London

Идентификаторы

NCT: NCT07069400 · STRIVE 002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗