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Diagnostic Stewardship for Ventilator-Associated Pneumonia

N/A

Recruiting

Led By Surbhi Leekha, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Patient age ≥ 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured over the 6 month control period and the 6 month intervention period

Awards & highlights

Study Summary

This trial tests if changing how lab reports respiratory culture results can reduce unnecessary antibiotics for ventilated ICU patients.

Who is the study for?

This trial is for adults over 18 who are in the ICU, on a ventilator, and have had a respiratory culture taken more than 48 hours after admission. It's not for patients with severe immune system issues, recent transplants or certain therapies, ECMO at culture time, prisoners, or if the lab rejected their sample.Check my eligibility

What is being tested?

The study tests whether changing how labs report respiratory test results can reduce unnecessary antibiotic use in ICU patients on ventilators without clinical signs of pneumonia. Patients will be compared based on modified versus standard result reporting methods.See study design

What are the potential side effects?

Since this trial involves modifying lab result reports rather than testing new medications or treatments, there are no direct side effects associated with the intervention being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured over the 6 month control period and the 6 month intervention period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured over the 6 month control period and the 6 month intervention period

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured over the 6 month control period and the 6 month intervention period for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of unnecessary antibiotic therapy

Secondary outcome measures

Antibiotic consumption

Antibiotic use outcome sensitivity analysis

Frequency of clinical diagnosis of VAP and tracheobronchitis

+3 more

Other outcome measures

Desirability of Outcome Ranking (DOOR)/Response Adjusted for Duration of Antibiotic Risk (RADAR)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

The lab will publish a modified report for respiratory cultures which do not meet clinical criteria for pneumonia and have growth of organisms (other than normal respiratory flora). The modified report will include the likelihood of colonization instead of reporting bacterial identification.

Group II: Control PeriodActive Control1 Intervention

Laboratory reporting of respiratory cultures will continue per regular or routine laboratory protocols (standard reporting).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,256 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,002 Total Patients Enrolled

George Washington UniversityOTHER

243 Previous Clinical Trials

453,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this trial currently being made available?

"Per clinicaltrials.gov, this research is currently recruiting participants with the trial having been initially posted on August 21st 2023 and last modified September 20th of that same year."

Answered by AI

What is the total population sample size for this research initiative?

"This trial requires 400 qualified individuals to participate and offers enrollment at various sites. These include Baylor College of Medicine in Houston, Texas and Virginia Commonwealth University in Richmond, Virginia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diagnostic Stewardship for Ventilator Associated Pneumonia

Surbhi Leekha 2023. "Diagnostic Stewardship for Ventilator Associated Pneumonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05989269.