Ventilator Associated PneumoniaPhase 4DATENCT05545735
The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days
A Phase 4 study of Ventilator Associated Pneumonia, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 27 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Surgical patient
- Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
- Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
- Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)
Who cannot join
- Age < 18 years
- Prior episode of VAP for the index admission
- VAP caused by any of the following pathogens:
- Methicillin-resistant Staphylococcus aureus (MRSA)
- Vancomycin-intermediate Staphylococcus aureus (VISA)
- Pseudomonas aeruginosa
Show all 21Show fewer
- Vancomycin-resistant Enterococcus (VRE)
- Acinetobacter baumanii
- Stenotrophomonas maltophilia
- Carbapenem-resistant Enterobacteriaceae (CRE)
- Extended-spectrum beta lactamase-producing gram-negative bacilli
- Causative pathogen not sensitive to choice of initial empiric antibiotic
- Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis
- Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring > 1 vasopressor (17)
- Current or recent (within 30 days) use of immunosuppressive medications
- LOS > 72 hours at a transferring facility
- Pregnancy or lactation
- Legal arrest or incarceration
- Moribund state in which death is imminent
- ECMO (Extracorporeal membrane oxygenation)
- Extubation prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Antibiotic Therapy for Early (DATE) Ventilator-Associated Pneumonia (VAP) Trial: A Surgical Infection Society Multicenter Randomized Clinical Trial of 4 vs. 7 Days of Definitive Antibiotic Therapy for Early VAP
The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Standard of Care Antibiotic Therapy
- 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.
Standard of Care Antibiotic TherapyDrug
Antibiotics will be administered as per the standard of care orally via tablet
| Study group | Role | What they receive |
|---|---|---|
| 4 Days of Antibiotics Group | Experimental | Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Receives: Drug: Standard of Care Antibiotic Therapy |
| 7 Days of Antibiotics Group | Active comparator | Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Receives: Drug: Standard of Care Antibiotic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Reoccurring VAP
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Measured: Up to 21 days
Antibiotic Free Days
The number of days where participant did not require the use of antibiotics
Measured: Up to 30 days
Secondary outcomes (11)
Number of Days of Antibiotic Exposure
The number of days when the participant received antibiotics
Measured: Up to 30 days
Amount of Antibiotic Exposure
Antibiotic exposure will be expressed as the total number of antibiotic days, defined as one antibiotic agent administered for one day. For example, if a patient receives two different antibiotics for five days, this equals 10 antibiotic days. The "number of antibiotics used" refers to the number of different antibiotic agents administered per day, not the number of individual doses or pills.
Measured: Up to 30 days
Clinical Improvement as Measured by the Change in Clinical Pulmonary Infection Score (CPIS) From the First Study Day to the Last
Clinical improvement will be measured comparing the difference from the first study day to the last study day using daily Clinical Pulmonary Infection Score (CPIS) clinical score while enrolled in the study. CPIS has a total score ranging from 0 to 12 where a score of less than 6 indicates that the lung infection is considered controlled. A negative change may suggest improvement while a positive difference may suggest a worsening.
Measured: From baseline to the last study day, up to 30 days
Number of Participants With VAP Relapse
VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.
Measured: Up to 30 days
Ventilator-free Days
The average number of days participants did not use a ventilator
Measured: Up to 30 days
The Number of Participants With Empyema
The number of participants with empyema
Measured: Up to 30 days
The Number of Participants That Received a Tracheostomy
The number of participants that received a tracheostomy
Measured: Up to 30 days
The Number of Participants With Non-pulmonary Infections
The number of participants with Non-pulmonary infections
Measured: Up to 30 days
ICU-free Days
The average number of days participants were not in the ICU
Measured: Up to 30 days
Hospital Length Of Stay
Number of days participant was admitted in the hospital
Measured: Up to 1 year
In-hospital Mortality
The number of participants that died while admitted in the hospital will be reported
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start8 May 2023
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Why it stopped: The rate of enrollment was slower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Meizoso, University of Miami
- Investigators
- Jonathan Meizoso, MD, MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545735
- Sponsor's protocol ID
- 20211211
- Acronym
- DATE
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2022
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Antibiotic Therapy for Early (DATE) Ventilator-Associated Pneumonia (VAP) Trial: A Surgical Infection Society Multicenter Randomized Clinical Trial of 4 vs. 7 Days of Definitive Antibiotic Therapy for Early VAP
- ClinicalTrials.gov ID
- NCT05545735
- Acronym / sponsor ID
- DATE / 20211211
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The rate of enrollment was slower than expected
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Posted 16 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 Days of Antibiotics Group | Experimental | Drug: Standard of Care Antibiotic TherapyParticipants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). |
| 7 Days of Antibiotics Group | Active comparator | Drug: Standard of Care Antibiotic TherapyParticipants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical patient
- Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
- Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
- Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)
Key exclusion criteria (21 listed)
- Age < 18 years
- Prior episode of VAP for the index admission
- VAP caused by any of the following pathogens:
- Causative pathogen not sensitive to choice of initial empiric antibiotic
- Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis
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 |
|---|---|---|
| Standard of Care Antibiotic TherapyAntibiotics will be administered as per the standard of care orally via tablet | Drug | 4 Days of Antibiotics Group, 7 Days of Antibiotics Group |
Primary outcome
Number of Participants With Reoccurring VAP
Time frame: Up to 21 days
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Antibiotic Free Days
Time frame: Up to 30 days
The number of days where participant did not require the use of antibiotics
11 secondary outcomes
Number of Days of Antibiotic Exposure
Time frame: Up to 30 days
Amount of Antibiotic Exposure
Time frame: Up to 30 days
Clinical Improvement as Measured by the Change in Clinical Pulmonary Infection Score (CPIS) From the First Study Day to the Last
Time frame: From baseline to the last study day, up to 30 days
Number of Participants With VAP Relapse
Time frame: Up to 30 days
Ventilator-free Days
Time frame: Up to 30 days
The Number of Participants With Empyema
Time frame: Up to 30 days
The Number of Participants That Received a Tracheostomy
Time frame: Up to 30 days
The Number of Participants With Non-pulmonary Infections
Time frame: Up to 30 days
ICU-free Days
Time frame: Up to 30 days
Hospital Length Of Stay
Time frame: Up to 1 year
In-hospital Mortality
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jonathan Meizoso, MD, MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Ventilator Associated Pneumonia, run by University of Miami at 1 site 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 21 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: stopped early, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Reoccurring VAP (time frame: Up to 21 days). The study lists 2 primary outcomes in all. 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 16 Jan 2026.