Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03865602
Eligibility Criteria:
Inclusion Criteria:
1. Admitted from the emergency department to inpatient or observation status at one of: Carolinas Medical Center, Carolinas Medical Center - Mercy, or Atrium Health Northeast;
2. ≥18 years of age upon admission;
3. oral/parenteral antibiotic or bacterial culture order within 24 hours of emergency department presentation and
1. culture drawn first, antibiotics ordered within 48 hours or
2. antibiotics ordered first, culture ordered within 48 hours (adapted from criteria applied in development of the Third International Consensus Definitions for Sepsis and Septic Shock)
4. deemed as high-risk for 30-day readmission (i.e., ≥ 20%) or 30-day mortality (i.e., ≥ 10%) using risk-scoring models
5. not discharged at the time of patient list generation
Exclusion Criteria:
1. prior randomization to either STAR or usual care study arms;
2. not a North Carolina resident or residence \>2.5-hour drive time from treating hospital;
3. the only antibiotic associated with patient is administered in the operating room as this likely represents pre-operative infection prophylaxis and not presumed infection;
4. patients transferred from other acute care hospitals;
5. patients with a change in code status (i.e., do not resuscitate, do not intubate) within 24 hours after admission due to the general assumption of increased risk of exposure to less aggressive treatment;
6. patients with infection ruled out during the index hospitalization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03865602
Study Brief:
Protocol Section:
NCT03865602