What side effects are associated with this type of intervention?

Common treatments for infections, such as beta-lactam antibiotics (penicillins, cephalosporins) and fluoroquinolones, are associated with various side effects. Beta-lactams can cause allergic reactions, ranging from mild rashes to severe anaphylaxis. Fluoroquinolones are linked to gastrointestinal disturbances, tendonitis, and increased risk of Clostridioides difficile infection. Both classes of antibiotics can contribute to the development of antibiotic-resistant bacteria. It is crucial to use these medications judiciously to minimize adverse effects and resistance.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of severe and resistant infections, including vancomycin, linezolid, and ceftaroline. Vancomycin is often used for life-threatening MRSA infections, while linezolid and ceftaroline are newer options with growing evidence of effectiveness. TMP-SMX, although less effective than vancomycin in some studies, is also used for serious MRSA infections. These drugs are part of ongoing efforts to optimize antimicrobial selection and duration, aiming to improve patient outcomes and reduce the development of drug-resistant bacteria.

What other types of research exist?

Promising novel alternatives to real-time antimicrobial prescription review for optimizing antimicrobial selection and duration include: 1) Computer-assisted antimicrobial monitoring programs that compile and analyze data on antimicrobial use and resistance patterns, allowing for more informed decision-making. 2) Implementation of algorithms designed to evaluate and optimize antimicrobial use based on specific criteria, which can streamline the review process and improve adherence to guidelines. 3) Adoption of new treatment guidelines and protocols that incorporate recent evidence and best practices for antimicrobial use, potentially reducing unnecessary prescriptions and improving patient outcomes.

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Post-Discharge Antimicrobial Review for Infections

N/A

Waitlist Available

Research Sponsored by Iowa City Veterans Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2-week-period through study completion (48 weeks total)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method to review and improve antibiotic prescriptions for hospitalized patients when they are discharged. The aim is to ensure that these patients receive only necessary and appropriate antibiotics, reducing unnecessary use and resistance.

Who is the study for?

This trial is for hospitals where the local stewardship team agrees to try a new method on at least one inpatient service or ward. It's not for hospitals that already have a process to review antimicrobial prescriptions when patients leave the hospital.

What is being tested?

The study is testing a novel 'prospective audit-and-feedback' approach aimed at improving how antibiotics are prescribed after patients are discharged from the hospital, ensuring better selection and duration of use.

What are the potential side effects?

Since this trial focuses on improving prescription practices rather than administering drugs directly, it does not involve side effects in the traditional sense. However, improved prescribing can reduce unnecessary drug exposure and associated risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2-week-period through study completion (48 weeks total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2-week-period through study completion (48 weeks total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2-week-period through study completion (48 weeks total) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-discharge antibiotic length of therapy

Secondary study objectives

Inpatient antibiotic length of therapy

Percentage of participants with hospital readmission

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective audit-and-feedback at dischargeExperimental Treatment1 Intervention

When hospitals are in the intervention arm, they will perform the audit-and-feedback process focused on patients receiving antimicrobials who have an anticipated discharge.

Group II: Standard of careActive Control1 Intervention

When hospitals are in the control arm, they will not perform a stewardship process that focuses on hospital discharge.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prospective audit-and-feedback

2023

N/A

~10

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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

Antibiotics, the primary treatment for bacterial infections, work by targeting specific bacterial functions or structures, such as cell wall synthesis (e.g., beta-lactams like penicillin), protein synthesis (e.g., tetracyclines, macrolides), DNA replication (e.g., fluoroquinolones), and metabolic pathways (e.g., sulfonamides). Optimizing the selection and duration of antibiotic therapy is crucial for effectively eradicating infections, minimizing side effects, and preventing antibiotic resistance. This is particularly important in the context of real-time antimicrobial prescription review, which aims to ensure the most appropriate and effective use of antibiotics.