Ventilator Associated PneumoniaNCT05989269
Diagnostic Stewardship for Ventilator Associated Pneumonia
A study testing Modified lab reporting in people with Ventilator Associated Pneumonia, run by University of Maryland, Baltimore at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Modified lab reporting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland
Baltimore, Maryland, 21201
Baylor College of Medicine
Houston, Texas, 77030
Virginia Commonwealth University
Richmond, Virginia, 23284
About this study
Official title: Diagnostic Stewardship for Ventilator Associated Pneumonia: A Pragmatic Cluster-randomized Crossover Trial of a Hybrid Order-review and Laboratory Reporting Intervention
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.
Read the detailed description
The specific aims of this project are:
Specific Aim 1: In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers, evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use, VAP diagnoses, and adverse events.
Hypothesis: A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs. control periods across all sites, without a change in adverse events, is expected.
Specific Aim 2: Evaluate overall impact of intervention including clinical and antibiotic outcomes using the "Desirability of Outcome Ranking (DOOR)/ Response Adjusted for Duration of Antibiotic Risk (RADAR)" methodology.
Hypothesis: A change in overall patient outcomes (better DOOR ranking, accounting for duration of antibiotic use) in the intervention vs. control period is expected.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Modified lab reporting
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified lab reportingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Modified lab reporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Not on empiric antibiotic(s), new antibiotic started based on index respiratory culture result
- Not on empiric antibiotic(s), no new antibiotics initiated based on culture result
- On empiric antibiotic(s), changed based on index respiratory culture, completed course for VAP
- On empiric antibiotic(s), continued without change following index respiratory culture, completed course for VAP
- On empiric antibiotic(s), antibiotics discontinued based on culture results
- 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".
Measured: Respiratory culture collection date through day 28 or patient discharge
Secondary outcomes (6)
Antibiotic consumption
To understand the impact on antibiotic use in ICU patients, we will measure the duration of antibiotic therapy for study patients, unit-level total antibiotic days of therapy (DOTs) standardized to patient census, and unit-level respiratory antibiotic days of therapy (DOTs) standardized to patient census.
Measured: Measured over the 6 month control period and the 6 month intervention period
Frequency of clinical diagnosis of VAP and tracheobronchitis
Measurement of this outcome will help understand how modification of reporting would influence the likelihood of a patient receiving a diagnosis of VAP. The clinical diagnosis of VAP is an intermediate outcome that precedes the endpoint of antibiotic use. Because there are no consensus definitions for VAP, we will use the treating clinician's documentation of pneumonia or VAP and treatment for those conditions to capture this outcome. Similarly, clinical diagnosis of tracheobronchitis within 7 days after the index culture will also be recorded.
Measured: Measured within the 7 days after the index respiratory culture
Antibiotic use outcome sensitivity analysis
We will perform a sensitivity analysis of the impact on antibiotic use outcomes after excluding patients diagnosed with tracheobronchitis within 7 days of index culture. The hypothesis is that the intervention will have limited impact on those diagnosed and treated for tracheobronchitis, and thus, we may see a larger difference between intervention and control when excluding patients with diagnoses of tracheobronchitis.
Measured: Measured within the 7 days after the index respiratory culture
Number of Ventilator-free days
Ventilator-free days is defined as the number of calendar days within 28 days after the index respiratory culture on which the patient was not mechanically ventilated. Any patient dying within 28 days of the index respiratory culture collection will be assigned zero ventilator-free days. Ventilator-free days will be compared between the intervention and control periods for all study ICUs combined, and by hospital.
Measured: Measured within the 28 days after the index respiratory culture
Frequency of provider requests for complete reports
Frequency of requests for complete reports in the intervention period - these data are applicable in the intervention period only. This will be a primarily descriptive analysis to help us understand if the intervention worked as intended i.e., how frequently did clinicians still want the full report with organism identification despite the nudge to consider asymptomatic colonization.
Measured: Measured during the 6 month intervention period
Incidence of Adverse Events
Death, bacteremia, and septic shock (from any cause) within 7 days of the index culture order will be recorded as potential significant adverse events from a delayed or missed true VAP diagnosis or delay in initiation of appropriate antimicrobial therapy. Two-person adjudication will be used to determine whether the above events were attributed to the intervention, during the intervention period. Rates of these events will be compared between intervention and control periods individually for each event, and as a combined adverse event outcome.
Measured: Measured within the 7 days after the index respiratory culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Aug 2023
- Primary completion31 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, George Washington University, Baylor College of Medicine, Virginia Commonwealth University
- Responsible party
- Principal investigator, Surbhi Leekha, University of Maryland, Baltimore
- Investigators
- Surbhi Leekha, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989269
- Sponsor's protocol ID
- HP-00100090
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Stewardship for Ventilator Associated Pneumonia: A Pragmatic Cluster-randomized Crossover Trial of a Hybrid Order-review and Laboratory Reporting Intervention
- ClinicalTrials.gov ID
- NCT05989269
- Acronym / sponsor ID
- HP-00100090
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, George Washington University, Baylor College of Medicine, Virginia Commonwealth University
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The specific aims of this project are:
Specific Aim 1: In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers, evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use, VAP diagnoses, and adverse events.
Hypothesis: A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs. control periods across all sites, without a change in adverse events, is expected.
Specific Aim 2: Evaluate overall impact of intervention including clinical and antibiotic outcomes using the "Desirability of Outcome Ranking (DOOR)/ Response Adjusted for Duration of Antibiotic Risk (RADAR)" methodology.
Hypothesis: A change in overall patient outcomes (better DOOR ranking, accounting for duration of antibiotic use) in the intervention vs. control period is expected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Period | No intervention | –Laboratory reporting of respiratory cultures will continue per regular or routine laboratory protocols (standard reporting). |
| Intervention | Other | Other: Modified lab reportingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified lab reportingIf 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. | Other | Intervention |
Primary outcome
Proportion of unnecessary antibiotic therapy
Time frame: Respiratory culture collection date through day 28 or patient discharge
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".
6 secondary outcomes
Antibiotic consumption
Time frame: Measured over the 6 month control period and the 6 month intervention period
Frequency of clinical diagnosis of VAP and tracheobronchitis
Time frame: Measured within the 7 days after the index respiratory culture
Antibiotic use outcome sensitivity analysis
Time frame: Measured within the 7 days after the index respiratory culture
Number of Ventilator-free days
Time frame: Measured within the 28 days after the index respiratory culture
Frequency of provider requests for complete reports
Time frame: Measured during the 6 month intervention period
Incidence of Adverse Events
Time frame: Measured within the 7 days after the index respiratory culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surbhi Leekha, MD principal investigator
University of Maryland, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified lab reporting in people with Ventilator Associated Pneumonia, run by University of Maryland, Baltimore at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of unnecessary antibiotic therapy (time frame: Respiratory culture collection date through day 28 or patient discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.