What side effects are associated with this type of intervention?

Common treatments for abdominal infections, particularly those involving broad-spectrum antibiotics, can lead to side effects such as gastrointestinal disturbances (nausea, vomiting, diarrhea), allergic reactions, and the development of antibiotic-resistant bacteria. Specific antibiotics like carbapenems may cause rash, neurotoxicity, and renal impairment. Prolonged antibiotic use also increases the risk of Clostridioides difficile infections, which can result in severe diarrhea and colitis.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of abdominal infections, including broad-spectrum agents like carbapenems (e.g., meropenem) and beta-lactam/beta-lactamase inhibitor combinations (e.g., piperacillin-tazobactam). These treatments are often used empirically to cover a wide range of potential pathogens, including resistant strains. The INSPIRE trial is investigating the use of real-time precision medicine through CPOE smart prompts to improve antibiotic stewardship by predicting the likelihood of resistant pathogen infections, potentially optimizing the use of these FDA-approved antibiotics.

What other types of research exist?

Promising alternatives to CPOE Smart Prompts for abdominal infection patients include AI-driven diagnostic tools that utilize machine learning algorithms to predict resistant pathogens, advanced microbiome analysis techniques that provide detailed insights into the patient's gut flora, and personalized medicine approaches that tailor treatments based on genetic and phenotypic data. These technologies offer real-time data analysis and high accuracy, potentially improving patient outcomes in 2024.

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Antibiotic Stewardship

INSPIRE Stewardship Bundle for Abdominal Infections

N/A

Waitlist Available

Led By Susan Huang, MD, MPH

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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT)

Secondary outcome measures

Antipseudomonal Antibiotic Days of Therapy per Empiric Day

Vancomycin Days of Therapy per Empiric Day

Other outcome measures

Empiric and Total Antibiotic Costs

Therapeutic procedure

Incidence of Hospital-Onset C. difficile

+3 more

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.

0 / 1Eligibility criteria met

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 Enterobacteriaceae: Risk factors for infection and impact of resistance on outcomes.