An International Observational Study of Adults With Acute Infection
ConditionInfectious Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThis is an observational study
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Day 28 Mortality
All-cause mortality
Time frame
Day 282
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.
Time frame
Day 283
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.
Time frame
Day 284
Ordinal outcome for clinical improvement - Day 7
For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.
Time frame
Day 7Sponsors and contacts
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Source ClinicalTrials.gov