N/A N=55,412 Randomized Other

The INSPIRE-ASP UTI Trial

Urinary Tract Infection (UTI)

Bottom Line

View on ClinicalTrials.gov: NCT03697096 ↗

Enrolled (actual)

55,412

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day — 35023; 25987 Extended-Spectrum Days-of-Therapy

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Routine Care (Other); INSPIRE CPOE Smart Prompt (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	35023; 25987	—
SECONDARY Vancomycin Days of Antibacterial Therapy Per Empiric Day	9795; 8071	—
SECONDARY Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	20792; 14186	—

Summary

The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen. Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.

Eligibility Criteria

Facility Inclusion Criteria:

HCA hospitals admitting adults for UTI
Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI. Prisoners were excluded from prompts and analysis.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03697096). 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.