Infectious Disease
Conditions
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.
Interventions
OTHERNo intervention
This is an observational study
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Argentina, Australia, Brazil, Côte d’Ivoire, Denmark, France, Germany, Greece, Guinea, Japan, Mexico, Peru, Singapore, South Korea, Spain, Thailand, Uganda, Ukraine, United Kingdom, United States, Zimbabwe
Contacts
CONTACTRebecca Schoenecker
PRINCIPAL_INVESTIGATORCavan Reilly, PhD
University of Minnesota
Outcome results
None listed