An International Observational Study of Adults With Acute Infection

Condition(s) studied

Investigational drug(s) / intervention(s)

No intervention: This is an observational study

Study 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

Primary outcome measure(s)

• Day 28 Mortality — Day 28
  All-cause mortality
• Days to recovery scale (DRS) — Day 28
  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.
• Time to Sustained Recovery — Day 28
  Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.
• Ordinal outcome for clinical improvement - Day 7 — Day 7
  For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
• Organ support free days — Day 28
  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.)
• The Sequential Organ Failure Assessment (SOFA) score - Day 28 — 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.

Trial sites (56)

+ 16 more sites — see the full list on the official registry below.