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NCT Number: NCT07069400

An International Observational Study of Adults With Acute Infection

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.

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Key information

Conditions

Infectious Disease Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Medico Platense (611-025), La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. Day 28 Mortality

    Time frame: Day 28

    All-cause mortality

  2. Days to recovery scale (DRS)

    Time frame: 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.

  3. Time to Sustained Recovery

    Time frame: Day 28

    Time to sustained recovery is defined as being discharged from the index hospitalization, followed by being alive and home for 14 days.

  4. Ordinal outcome for clinical improvement - Day 7

    Time frame: Day 7

    For respiratory infections, the WHO Ordinal Scale for Clinical Improvement may be assessed.

  5. Organ support free days

    Time frame: 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.)

  6. The Sequential Organ Failure Assessment (SOFA) score - Day 28

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Schoenecker

CONTACT

[email protected]

612-624-9644

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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