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The rate of enrollment was slower than expected
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Antibiotic Therapy | Drug | Antibiotics will be administered as per the standard of care orally via tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reoccurring VAP | VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy. | Up to 21 days |
| Antibiotic Free Days | The number of days where participant did not require the use of antibiotics | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Antibiotic Exposure | The number of days when the participant received antibiotics | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Meizoso, MD, MSPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 Days of Antibiotics Group | Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet |
| FG001 | 7 Days of Antibiotics Group | Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 Days of Antibiotics Group | Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reoccurring VAP | VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy. | Posted | Count of Participants | Participants | Up to 21 days |
|
All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first.
This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4 Days of Antibiotics Group | Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brain Death | Nervous system disorders | Systematic Assessment | Brain Death |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Meizoso | University of Miami | 305-585-1178 | jpmeizoso@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2023 | Oct 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| 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. | 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. | Up to 30 days |
| Ventilator-free Days | The average number of days participants did not use a ventilator | Up to 30 days |
| The Number of Participants With Empyema | The number of participants with empyema | Up to 30 days |
| The Number of Participants That Received a Tracheostomy | The number of participants that received a tracheostomy | Up to 30 days |
| The Number of Participants With Non-pulmonary Infections | The number of participants with Non-pulmonary infections | Up to 30 days |
| ICU-free Days | The average number of days participants were not in the ICU | Up to 30 days |
| Hospital Length Of Stay | Number of days participant was admitted in the hospital | Up to 1 year |
| In-hospital Mortality | The number of participants that died while admitted in the hospital will be reported | Up to 1 year |
| 7 Days of Antibiotics Group |
Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Subjects with causative pathogen sensitive to initial empiric antibiotic | Count of Participants | Participants |
|
|
|
| Primary | Antibiotic Free Days | The number of days where participant did not require the use of antibiotics | Posted | Mean | Standard Deviation | Days | Up to 30 days |
|
|
|
| Secondary | Number of Days of Antibiotic Exposure | The number of days when the participant received antibiotics | Posted | Mean | Standard Deviation | Days | Up to 30 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Antibiotic Days | Up to 30 days |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | Change of score on a scale | From baseline to the last study day, up to 30 days |
|
|
|
| Secondary | Number of Participants With VAP Relapse | VAP relapse will be reported as any recurrence of VAP caused by initial pathogen. | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | Ventilator-free Days | The average number of days participants did not use a ventilator | Posted | Mean | Standard Deviation | Days | Up to 30 days |
|
|
|
| Secondary | The Number of Participants With Empyema | The number of participants with empyema | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | The Number of Participants That Received a Tracheostomy | The number of participants that received a tracheostomy | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | The Number of Participants With Non-pulmonary Infections | The number of participants with Non-pulmonary infections | Posted | Count of Participants | Participants | Up to 30 days |
|
|
|
| Secondary | ICU-free Days | The average number of days participants were not in the ICU | Posted | Mean | Standard Deviation | Days | Up to 30 days |
|
|
|
| Secondary | Hospital Length Of Stay | Number of days participant was admitted in the hospital | Posted | Mean | Standard Deviation | Days | Up to 1 year |
|
|
|
| Secondary | In-hospital Mortality | The number of participants that died while admitted in the hospital will be reported | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
| 2 |
| 12 |
| 2 |
| 12 |
| 0 |
| 12 |
| EG001 | 7 Days of Antibiotics Group | Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet | 2 | 15 | 5 | 15 | 0 | 15 |
| Worsening Brain Bleed | Nervous system disorders | Systematic Assessment | Brain bleed became worse as compared to baseline |
|
| Above the Knee Amputation | Vascular disorders | Systematic Assessment | Amputation of the lower limb above the knee |
|
| Blood Stream Infection | Infections and infestations | Systematic Assessment | Blood Stream Infection |
|
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| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |