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Completed

NCT Number: NCT05423756

INSPIRE Trial for Skin and Soft Tissue Infections

The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

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Key information

Conditions

Skin and Soft Tissue (SST) Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riverside Community hospital, Riverside, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Facility Inclusion Criteria:

  • HCA Healthcare hospitals admitting adults for skin and soft tissue infection
  • Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age >=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.

Treatment and study plan

Arm 1: Routine Care

Other

Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.

Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection

Other

Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having a skin/soft tissue infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.

Primary outcomes

  1. Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day

    Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

    Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.

    Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.

    For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.

Secondary outcomes

  1. Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day

    Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

    Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given.

    Antipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.

    For example, 2 different antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.

Other outcomes

  1. Intensive Care Unit (ICU) Transfer [Safety Outcome 1]

    Time frame: Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods

    Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.

  2. Length-of-stay [Safety Outcome 2]

    Time frame: Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods

    Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.

  3. Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibiotic Treatment After Empiric Period

    Time frame: 12 months

    The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14.

    Note: this outcome is intended for a secondary manuscript

  4. Empiric and Total Antibiotic Costs

    Time frame: 12 months

    Empiric and total antibiotic costs for skin and soft tissue infection during hospitalization.

    Note: this outcome is intended for a secondary manuscript.

  5. Incidence of Hospital-Onset C. Difficile

    Time frame: 12 months

    Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14.

    Note: this outcome is intended for a secondary manuscript.

  6. Incidence of Hospital-Onset MDRO-Positive Cultures

    Time frame: 12 months

    Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets.

    Note: this outcome is intended for a secondary manuscript.

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Brigham and Women's Hospital
  • Hospital Corporation of America
  • Rush University
  • University of California, Irvine
  • University of Massachusetts, Amherst

Registry information

Official study title

The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Aug 26, 2025

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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