Diagnostic Stewardship for Ventilator Associated Pneumonia

NCT05989269 | Completed

• 1 other identifier: HP-00100090
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for patients who have respiratory cultures obtained, but do not meet clinical criteria for ventilator associated pneumonia (VAP). The main question it aims to answer is: Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit (ICU)? Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Proportion of unnecessary antibiotic therapy

  The primary efficacy outcome is change in proportion of unnecessary antibiotic therapy for presumed VAP in the intervention (modified reporting) period compared to control (standard reporting) period. Antibiotic use for VAP relative to the index respiratory culture will be classified as follows: 1. Not on empiric antibiotic(s), new antibiotic started based on index respiratory culture result 2. Not on empiric antibiotic(s), no new antibiotics initiated based on culture result 3. On empiric antibiotic(s), changed based on index respiratory culture, completed course for VAP 4. On empiric antibiotic(s), continued without change following index respiratory culture, completed course for VAP 5. On empiric antibiotic(s), antibiotics discontinued based on culture results 6. On empiric antibiotics(s), but this was not directed towards VAP Antibiotic use in categories a, c, and d will together be considered "unnecessary antibiotic therapy for VAP treatment".

  Respiratory culture collection date through day 28 or patient discharge

Secondary Outcomes (6)

• Antibiotic consumption

  Measured over the 6 month control period and the 6 month intervention period

• Frequency of clinical diagnosis of VAP and tracheobronchitis

  Measured within the 7 days after the index respiratory culture

• Antibiotic use outcome sensitivity analysis

  Measured within the 7 days after the index respiratory culture

• Number of Ventilator-free days

  Measured within the 28 days after the index respiratory culture

• Frequency of provider requests for complete reports

  Measured during the 6 month intervention period

Other Outcomes (1)

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

  Measured within the 28 days after the index respiratory culture

Study Arms (2)

Control Period

NO INTERVENTION

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

Intervention

OTHER

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.

Other: Modified lab reporting

Interventions

Modified lab reporting OTHER

If appropriateness of culturing i.e., clinical criteria for pneumonia testing does not meet the algorithm AND there is growth of one or more organism(s) that are not considered normal upper respiratory flora, during the intervention period, the result will be modified to reflect the likelihood of asymptomatic colonization.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient located on ICU unit included in the study
• Patient is mechanically ventilated
• Patient had respiratory culture sent \>48 hours after admission
• Patient age ≥ 18 years

You may not qualify if:

• Extra corporeal membrane oxygenation (ECMO) at time of respiratory culture
• Heart or lung transplant
• Culture rejected by lab per standard lab protocol
• Prisoners
• Severe immunosuppression as defined by:
• \<6 months from solid organ transplant (SOT) OR \<6 months from treatment for acute rejection following SOT
• Active treatment for lymphoreticular malignancies
• Neutropenic \< 1000
• Receiving lymphodepleting chemotherapy
• Allogeneic stem cell transplants \<6 months
• Autologous stem cell transplants or chimeric antigen receptor T-cell (CAR-T) therapy \<6 months out
• Allogeneic stem cell transplant with graft vs host disease (GVHD) or receiving 2 or more immunosuppressants
• Advanced or untreated human immunodeficiency virus (HIV) infection with CD4 \< 200
• Receiving biologics within 6 months

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Centers for Disease Control and Prevention: collaborator
• George Washington University: collaborator
• Baylor College of Medicine: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (3)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Surbhi Leekha, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Ordering care providers will not be aware if the test results are eligible for modified reporting or not.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a pragmatic cluster-randomized crossover trial in 6 adult ICUs (1 medical and 1 surgical ICU each at 3 hospitals). ICUs (clusters) will be randomized at the hospital-level (1:1) to a sequence of intervention (6 months) followed by control (6 months), or vice-versa. The study population is ventilated patients with respiratory culture orders but not meeting clinical pneumonia criteria, and organism(s) growing in respiratory culture. A research physician will evaluate likelihood of pneumonia using a standard clinical algorithm, within 24 hours of the order Mon-Fri. If pneumonia criteria are not met AND there is growth of organism(s) (except normal respiratory flora), during the intervention period, the culture report will be modified to reflect the likelihood of asymptomatic colonization instead of reporting bacterial identification. Clinicians may call the lab for identification and susceptibilities if necessary. During the control period, no modification to reporting will occur.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)