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Antibiotic Stewardship
INSPIRE Stewardship Bundle for Abdominal Infections
N/A
Waitlist Available
Led By Richard Platt, MD, MS
Research Sponsored by Harvard Pilgrim Health Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
-
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a computer system that helps doctors choose the best antibiotics for non-critically ill adults with abdominal infections. The system shows how likely it is that an infection is resistant to common antibiotics. This aims to improve treatment decisions and outcomes for these patients.
Who is the study for?
This trial is for HCA Healthcare hospitals that admit adults with abdominal infections and use MEDITECH electronic health record systems. It's not about individual patients, but the hospitals themselves are the 'subjects' being studied.
What is being tested?
The INSPIRE Trial compares usual antibiotic treatments in hospitals to a new method using computer prompts that help doctors guess if an infection is resistant to antibiotics. Hospitals are grouped and randomly assigned to one of these two approaches.
What are the potential side effects?
Since this trial focuses on hospital practices rather than direct patient interventions, it doesn't have typical side effects. However, changes in treatment protocols could indirectly affect patient outcomes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
N/A
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT)
Secondary study objectives
Antipseudomonal Antibiotic Days of Therapy per Empiric Day
Vancomycin Days of Therapy per Empiric Day
Other study objectives
Empiric and Total Antibiotic Costs
Therapeutic procedure
Incidence of Hospital-Onset C. difficile
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Arm 1: Routine CareActive Control1 Intervention
Continuation of routine antibiotic stewardship strategies.
Group II: Arm 2: INSPIRE Stewardship BundleActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for abdominal infections involve the use of broad-spectrum antibiotics that target a wide range of bacteria. These antibiotics work by inhibiting bacterial cell wall synthesis, protein synthesis, or DNA replication, effectively killing the bacteria or stopping their growth.
Precision medicine, such as the CPOE Smart Prompts trial, enhances this approach by using real-time data to predict the likelihood of resistant pathogen infections. This allows for more targeted antibiotic therapy, reducing the risk of ineffective treatment and promoting better patient outcomes.
For abdominal infection patients, this means a higher chance of receiving the right antibiotic quickly, minimizing complications and improving recovery rates.
Carbapenemase-producing <i>Enterobacteriaceae</i>: Risk factors for infection and impact of resistance on outcomes.
Carbapenemase-producing <i>Enterobacteriaceae</i>: Risk factors for infection and impact of resistance on outcomes.
Find a Location
Who is running the clinical trial?
Rush UniversityOTHER
45 Previous Clinical Trials
387,932 Total Patients Enrolled
Harvard Pilgrim Health CareLead Sponsor
59 Previous Clinical Trials
24,985,999 Total Patients Enrolled
HCA Healthcare, IncUNKNOWN
1 Previous Clinical Trials
102 Total Patients Enrolled
University of California, IrvineOTHER
566 Previous Clinical Trials
1,932,946 Total Patients Enrolled
University of Massachusetts, AmherstOTHER
81 Previous Clinical Trials
468,048 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,670 Previous Clinical Trials
11,878,164 Total Patients Enrolled
Richard Platt, MD, MSPrincipal InvestigatorHarvard Pilgrim Health Care Institute/Harvard Medical School
7 Previous Clinical Trials
6,427,881 Total Patients Enrolled
Susan Huang, MD, MPHPrincipal InvestigatorUC Irvine Division of Infectious Diseases
7 Previous Clinical Trials
356,378 Total Patients Enrolled
Shruti Gohil, MD, MPHStudy DirectorUC Irvine Division of Infectious Diseases
3 Previous Clinical Trials
220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/A
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Routine Care
- Group 2: Arm 2: INSPIRE Stewardship Bundle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.