INSPIRE Trial for Skin and Soft Tissue Infections | NCT05423756

Status Module

Name	Class
Hospital Corporation of America	INDUSTRY
University of California, Irvine	OTHER
University of Massachusetts, Amherst	OTHER
Brigham and Women's Hospital

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1: Routine Care	Active Comparator	Continuation of routine antibiotic stewardship strategies.	Other: Arm 1: Routine Care
Arm 2: INSPIRE Stewardship Bundle	Active Comparator	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.	Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arm 1: Routine Care	Other	Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Arm 1: Routine Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day	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.	First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

Secondary Outcomes

Measure	Description	Time Frame
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day	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

Measure	Description	Time Frame
Intensive Care Unit (ICU) Transfer [Safety Outcome 1]	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.	Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Shruti Gohil, MD, MPH	UC Irvine Division of Infectious Diseases	Study Director
Susan Huang, MD, MPH	UC Irvine Division of Infectious Diseases	Principal Investigator
Richard Platt, MD, MS	Harvard Pilgrim Health Care Institute/Harvard Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Riverside Community hospital		Riverside	California	92501	United States
Regional Medical Center of San Jose

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40208610	Result	Gohil SK, Septimus E, Kleinman K, Varma N, Sands KE, Avery TR, Mauricio A, Sljivo S, Rahm R, Roemer K, Cooper WS, McLean LE, Nickolay NG, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith KN, Meador B, Froman A, Eibensteiner K, Hayden MK, Kubiak DW, Burks C, Burgess LH, Calderwood MS, Perlin JB, Platt R, Huang SS. Improving Empiric Antibiotic Selection for Patients Hospitalized With Skin and Soft Tissue Infection: The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):680-691. doi: 10.1001/jamainternmed.2025.0887.
42268612

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
FG001	Arm 2: INSPIRE CPOE Bundle

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 24, 2020	May 9, 2025

Arm/Group Information

ID	Title	Description
BG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
BG001	Arm 2: INSPIRE CPOE Bundle	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: 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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (12 months)

- ParticipantsOG00029595
- ParticipantsOG00128242

Title	Measurements
	OG00043305

Secondary

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

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.

The total number of participants analyzed reported here is from the baseline and intervention periods

Posted

Number

Antipseudomonal Days-of-Therapy

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

ID	Title	Description
OG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
OG001	Arm 2: INSPIRE CPOE Bundle	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: 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.

Other Pre-specified

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

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.

The mean number of days to event here is from the the baseline and intervention periods

Posted

Mean

Standard Deviation

Days to event

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

ID	Title	Description
OG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
OG001	Arm 2: INSPIRE CPOE Bundle	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: 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.

Other Pre-specified

Length-of-stay [Safety Outcome 2]

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.

The mean number of days to event here is from the baseline and intervention periods

Posted

Mean

Standard Deviation

Days to event

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

ID	Title	Description
OG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
OG001	Arm 2: INSPIRE CPOE Bundle	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: 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.

Other Pre-specified

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

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

Note: this outcome is intended for a secondary manuscript

Not Posted

Dec 2026

12 months

Participants

Other Pre-specified

Empiric and Total Antibiotic Costs

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

Note: this outcome is intended for a secondary manuscript.

Not Posted

Dec 2026

12 months

Participants

Other Pre-specified

Incidence of Hospital-Onset C. Difficile

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

Note: this outcome is intended for a secondary manuscript.

Not Posted

Dec 2026

12 months

Participants

Other Pre-specified

Incidence of Hospital-Onset MDRO-Positive Cultures

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.

Not Posted

Dec 2026

12 months

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1: Routine Stewardship	Continuation of routine antibiotic stewardship strategies. Arm 1: Routine Care: Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	0	60,932	0	60,932	0	60,932
EG001	Arm 2: INSPIRE CPOE Bundle	Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization. Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection: 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.	0	57,630	0	57,630	0	57,630