N/A N=57,837 Randomized Other

INSPIRE Trial for Skin and Soft Tissue Infections

Skin and Soft Tissue (SST) Infection

Bottom Line

View on ClinicalTrials.gov: NCT05423756 ↗

Enrolled (actual)

57,837

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day — 43305; 40156; 43927; 30287 Extended-Spectrum Days-of-Therapy

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Arm 1: Routine Care (Other); Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Harvard Pilgrim Health Care
Primary completion: May 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day	43305; 40156; 43927; 30287	—
SECONDARY Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	43305; 38059; 43927; 30287	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05423756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.