Abdominal (ABD) InfectionNCT05423743

INSPIRE Trial for Abdominal Infections

A study testing Arm 1: Routine Care and Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection in people with Abdominal (ABD) Infection, run by Harvard Pilgrim Health Care at 101 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The INSPIRE Abdominal 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal (ABD) Infection
What is being tested?: Arm 1: Routine Care and Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198,480 participants
Where: 101 sitesUnited States
Study dates: 1 Jan 2023to 9 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Facility Inclusion Criteria:

HCA Healthcare hospitals admitting adults for abdominal 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 abdominal infection.

Trial locations and contacts

101 sites in 1 country.

City, postcode or hospital

101 sites in 1 country

United States101 sites

Medical City Arlington
Arlington, Texas, 76015
The Medical Center of Aurora
Aurora, Colorado, 80012
St. David's Medical Center
Austin, Texas, 78705
St. David's North Austin Medical Center
Austin, Texas, 78758
LewisGale Hospital Montgomery
Blacksburg, Virginia, 24060
TriStar Greenview Regional Hospital
Bowling Green, Kentucky, 41204
Blake Medical Center
Bradenton, Florida, 34209
Brandon Regional Hospital
Brandon, Florida, 33511
Oak Hill Hospital
Brooksville, Florida, 34613
Valley Regional Medical Center
Brownsville, Texas, 78526
Trident Medical Center
Charleston, South Carolina, 29406
Parkridge Medical Center
Chattanooga, Tennessee, 37404
Parkridge East Hospital
Chattanooga, Tennessee, 37412
HCA Houston Healthcare Conroe
Conroe, Texas, 77304
Corpus Christi Medical Center - Bay Area
Corpus Christi, Texas, 78412
Corpus Christi Medical Center - Doctors Regional
Corpus Christi, Texas, 78412
Corpus Christi Medical Center - Heart Hospital
Corpus Christi, Texas, 78412
Lakeview Regional Medical Center
Covington, Louisiana, 70433
Medical City Dallas
Dallas, Texas, 75230
Medical City Denton
Denton, Texas, 76210
TriStar Horizon Medical Center
Dickson, Tennessee, 37055
Fairview Park Hospital
Dublin, Georgia, 31040
Las Palmas Medical Center
El Paso, Texas, 79902
Del Sol Medical Center
El Paso, Texas, 79925
Swedish Medical Center
Englewood, Colorado, 80113
Englewood Community Hospital
Englewood, Florida, 34223
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, 32547
Medical City Fort Worth
Fort Worth, Texas, 76104
Medical City Alliance
Fort Worth, Texas, 76177
Medical City Frisco
Frisco, Texas, 75034
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950
TriStar Hendersonville Medical Center
Hendersonville, Tennessee, 37075
HCA Houston Healthcare West
Houston, Texas, 77082
Regional Medical Center of Bayonet Point
Hudson, Florida, 34667
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83404
Centerpoint Medical Center
Independence, Missouri, 64057
Medical City Las Colinas
Irving, Texas, 75039
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
Research Medical Center
Kansas City, Missouri, 64132
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339
Lake City Medical Center
Lake City, Florida, 32055
Largo Medical Center
Largo, Florida, 33770
Southern Hills Hospital & Medical Center
Las Vegas, Nevada, 89109
Sunrise Hospital & Medical Center
Las Vegas, Nevada, 89109
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063
Medical City Lewisville
Lewisville, Texas, 75057
Methodist Hospital Northeast
Live Oak, Texas, 78233
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Northwest Medical Center
Margate, Florida, 33063
Rio Grande Regional Hospital Main Campus
McAllen, Texas, 78503
Medical City McKinney
McKinney, Texas, 75069
Mercy Hospital
Miami, Florida, 33133
Kendall Regional Medical Center
Miami, Florida, 33175
Grand Strand Medical Center
Myrtle Beach, South Carolina, 29572
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
TriStar Southern Hills Medical Center
Nashville, Tennessee, 37211
Tulane Medical Center
New Orleans, Louisiana, 70112
Medical City North Hills
North Richland Hills, Texas, 76180
Ogden Regional Medical Center
Ogden, Utah, 84405
Orange Park Medical Center
Orange Park, Florida, 32073
Menorah Medical Center
Overland Park, Kansas, 66209
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Oviedo Medical Center
Oviedo, Florida, 32765
Gulf Coast Regional Medical Center
Panama City, Florida, 32405
HCA Houston Healthcare Southeast
Pasadena, Texas, 77504
HCA Houston Healthcare Pearland
Pearland, Texas, 77584
Medical City Plano
Plano, Texas, 75075
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952
LewisGale Hospital Pulaski
Pulaski, Virginia, 24301
Reston Hospital Center
Reston, Virginia, 20190
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, 23225
Henrico Doctors' Hospital
Richmond, Virginia, 23229
Riverside Community Hospital
Riverside, California, 92501
St. David's Round Rock Medical Center
Round Rock, Texas, 78681
LewisGale Medical Center
Salem, Virginia, 24153
Methodist Hospital Texsan
San Antonio, Texas, 78201
Methodist Hospital Metropolitan
San Antonio, Texas, 78212
Methodist Hospital | Specialty and Transplant
San Antonio, Texas, 78229
Methodist Hospital
San Antonio, Texas, 78229
Regional Medical Center of San Jose
San Jose, California, 95116
Good Samaritan Hospital
San Jose, California, 95124
Doctors Hospital of Sarasota
Sarasota, Florida, 34233
TriStar StoneCrest Medical Center
Smyrna, Tennessee, 37167
Palms of Pasadena
St. Petersburg, Florida, 33707
Northside Hospital
St. Petersburg, Florida, 33709
St. Petersburg General Hospital
St. Petersburg, Florida, 33710
South Bay Hospital
Sun City Center, Florida, 33573
Capital Regional Medical Center
Tallahassee, Florida, 32308
HCA Florida South Tampa Hospital
Tampa, Florida, 33609
HCA Florida West Tampa Hospital
Tampa, Florida, 33615
HCA Houston Healthcare Mainland
Texas City, Texas, 77591
North Suburban Medical Center
Thornton, Colorado, 80229
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91362
Medical Center of Trinity
Trinity, Florida, 34655
Medical City Weatherford
Weatherford, Texas, 76086
HCA Houston Healthcare Clear Lake
Webster, Texas, 77598
West Hills Hospital & Medical Center
West Hills, California, 91307
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407
Wesley Medical Center
Wichita, Kansas, 67214
Wesley Woodlawn Hospital & ER
Wichita, Kansas, 67220

Other trials in United States

About this study

Official title: The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections

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.

Conditions: Abdominal (ABD) Infection
Being tested: Arm 1: Routine Care, Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection
Keywords: ABD, CPOE, Empiric Therapy
Medical subject headings: Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm 1: Routine CareOther
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
Arm 2: INSPIRE Stewardship Bundle for Abdominal InfectionOther
Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having an abdominal 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.

Study groups in NCT05423743
Study group	Role	What they receive
Arm 1: Routine Care	Active comparator	Continuation of routine antibiotic stewardship strategies. Receives: 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 abdominal infection in the first 3 days of hospitalization. Receives: Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Vancomycin Days of Antibacterial Therapy 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.
Vancomycin days-of-therapy per empiric day is defined as the the number of days that vancomycin is received by a patient, averaged over the empiric period, and summed across all participants. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
Measured: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
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.
Measured: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20239 May 2025

First posted21 Jun 2022
Study start1 Jan 2023
Primary completion9 May 2025
Study completion9 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Abdominal (ABD) InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking: None (open label)
Enrolment: 198,480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05423743
Sponsor's protocol ID: PH000763B_ABD
Status last verified: Aug 2025
First submitted: 14 Jun 2022
Last updated: 22 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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 Abdominal Infection: The INSPIRE 4 Cluster Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):733-743. doi: 10.1001/jamasurg.2025.1108.
PubMed 40208583
Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
PubMed 42268612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Not yet recruitingObservational study
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury

All Abdominal (ABD) Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections
ClinicalTrials.gov ID: NCT05423743
Acronym / sponsor ID: PH000763B_ABD
Conditions: Abdominal (ABD) Infection
Keywords: ABD, CPOE, Empiric Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 198,480 participants (actual)
Lead sponsor: Harvard Pilgrim Health CareUniversity, hospital or other
Collaborators: Hospital Corporation of America, University of California, Irvine, University of Massachusetts, Amherst, Brigham and Women's Hospital, Rush University
Study start: 1 Jan 2023 (actual)
Primary completion: 9 May 2025 (actual)
Study completion: 9 May 2025 (actual)
First posted: 21 Jun 2022 (actual)
Results: Posted 15 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.

Arm	Type	Receives
Arm 1: Routine Care	Active comparator	Other: Arm 1: Routine CareContinuation of routine antibiotic stewardship strategies.
Arm 2: INSPIRE Stewardship Bundle	Active comparator	Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal InfectionUse 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 abdominal infection in the first 3 days of hospitalization.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arm 1: Routine CareRoutine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.	Other	Arm 1: Routine Care
Arm 2: INSPIRE Stewardship Bundle for Abdominal InfectionQuality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having an abdominal 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	Arm 2: INSPIRE Stewardship Bundle

Primary outcome

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.

2 secondary outcomes

Vancomycin Days of Antibacterial Therapy Per Empiric Day
Time frame: First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
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

Results and safety

Results posted to the registry on 15 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Routine Stewardship	46,725	46,725
Arm 2: INSPIRE CPOE Bundle	46,751	46,751

Primary outcome: 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. Number. Unit: Extended-Spectrum Days-of-Therapy

Measure	Arm 1: Routine Stewardship n = 101109	Arm 2: INSPIRE CPOE Bundle n = 97371
Baseline (12 months)	68616	68679
Intervention (12 months)	76605	50001

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months (baseline), 12 months (intervention). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Routine Stewardship	0 of 101,109 (0%)	0 of 101,109 (0%)	0 of 101,109
Arm 2: INSPIRE CPOE Bundle	0 of 97,371 (0%)	0 of 97,371 (0%)	0 of 97,371

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40208583Gohil 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 Abdominal Infection: The INSPIRE 4 Cluster Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):733-743. doi: 10.1001/jamasurg.2025.1108.
Derived from this study: PubMed 42268612Gohil SK, Avery TR, Kleinman K, Septimus E, Mauricio A, Sands KE, Varma N, Sljivo S, Roemer K, Cooper WS, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith-Sells KN, Hayden MK, Kubiak DW, Burks C, Platt R, Huang SS, Baker MA. Improving Empiric Antibiotic Selection for Patients With Cancer Hospitalized With Infection: Secondary Analysis of the INSPIRE Cluster Randomized Trials. JAMA Netw Open. 2026 Jun 1;9(6):e2616611. doi: 10.1001/jamanetworkopen.2026.16611.
Individual participant dataSharing planned: No

Related trials for Abdominal (ABD) Infection

Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
Not yet recruitingObservational study
High-Sensitivity Troponin T Kinetics and 30-Day Outcomes After Major Abdominal Surgery (TROP-MAS)
Myocardial Infarction (MI), Perioperative Myocardial Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shruti Gohil, MD, MPH study director

UC Irvine Division of Infectious Diseases

Susan Huang, MD, MPH principal investigator

UC Irvine Division of Infectious Diseases

Richard Platt, MD, MS principal investigator

Harvard Pilgrim Health Care Institute/Harvard Medical School

101 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05423743, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.