Shortened Antibiotic Therapy for Ventilator-Associated Pneumonia (DATE Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJonathan Meizoso, MD, MSPH
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Miami
No Placebo Group
Prior Safety Data
Approved in 6 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications or have been on antibiotics for more than 5 of the last 10 days, you may not be eligible to participate.
What data supports the effectiveness of the treatment for ventilator-associated pneumonia?
Research suggests that a shorter course of antibiotic therapy (7-8 days) is effective for most patients with ventilator-associated pneumonia and does not increase the risk of death. Additionally, using broad-spectrum antibiotics initially and then focusing treatment based on specific test results can improve outcomes and reduce the chance of resistance.
12345Is shortened antibiotic therapy for ventilator-associated pneumonia safe for humans?
Research suggests that a shorter duration of antibiotic therapy (7-8 days) for ventilator-associated pneumonia is generally safe and does not increase the risk of death.
45678How is the Standard of Care Antibiotic Therapy for ventilator-associated pneumonia different from other treatments?
The Standard of Care Antibiotic Therapy for ventilator-associated pneumonia is unique because it involves a shorter duration of treatment, typically 7-8 days, which is considered adequate for most patients and helps reduce the risk of developing antibiotic resistance without increasing mortality.
145910Eligibility Criteria
This trial is for surgical patients with early ventilator-associated pneumonia (VAP) that occurred within 2-7 days of intubation, who haven't been in the hospital for more than 10 days at VAP diagnosis. Participants must be able to consent or have a representative do so. Excluded are those with septic shock, recent immunosuppressant use, legal incarceration, prior VAP this admission, certain resistant infections, extensive recent antibiotics use, imminent death prognosis, transfer from another facility after 72 hours+, and pregnant or breastfeeding women.Inclusion Criteria
I am scheduled for or have had surgery.
I was in the hospital for less than 10 days when diagnosed with VAP.
Exclusion Criteria
I was hospitalized for more than 72 hours before being transferred.
My lung infection is caused by a drug-resistant bacteria.
I have septic shock and need more than one medication to maintain my blood pressure.
I am under 18 years old.
Participant Groups
The study tests if shorter antibiotic treatment (4 days) is as safe and effective as the standard duration (7 days) for early ventilator-associated pneumonia. The goal is to minimize antibiotic-related side effects without compromising patient safety.
2Treatment groups
Experimental Treatment
Active Control
Group I: 4 Days of Antibiotics GroupExperimental Treatment1 Intervention
Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Group II: 7 Days of Antibiotics GroupActive Control1 Intervention
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 is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
🇺🇸 Approved in United States as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
🇨🇦 Approved in Canada as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
🇯🇵 Approved in Japan as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
🇨🇳 Approved in China as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
🇨🇭 Approved in Switzerland as Standard Antibiotic Therapy for:
- Ventilator-associated pneumonia (VAP)
- Bacterial infections
- Respiratory tract infections
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Jackson Memorial HospitalMiami, FL
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Who is running the clinical trial?
University of MiamiLead Sponsor
References
Optimal duration of the antimicrobial treatment of ventilator-acquired pneumonia. [2008]The optimal duration of antimicrobial treatment of patients with ventilator-associated pneumonia is a major concern for clinicians. We looked for the evidence that a short course of therapy (
Therapy for ventilator-associated pneumonia: what works, what doesn't. [2005]Ventilator-associated pneumonia is a common cause of morbidity and mortality in critically ill patients. Inappropriate initial antimicrobial therapy is associated with poor outcome. An initial aggressive strategy using broad-spectrum antibiotics based on the local distribution of pathogens, patient risk factors, and antimicrobial characteristics; followed by focused therapy based on microbiologic studies, will help minimize the chance of inappropriate therapy and the emergence of resistance.
Diagnosis and treatment of ventilator-associated pneumonia--impact on survival. A decision analysis. [2019]To determine the impact of antibiotic treatment of ventilator-associated pneumonia (VAP) on survival.
Variability in antibiotic prescribing patterns and outcomes in patients with clinically suspected ventilator-associated pneumonia. [2022]To describe the variation in clinical practice strategies for the treatment of suspected ventilator-associated pneumonia (VAP) in a population of critically ill patients, and to determine whether initial empiric treatment with certain antibiotics, monotherapy vs combination antibiotic therapy, or appropriate vs inappropriate antibiotic therapy is associated with survival, length of hospital stay, or days free of antibiotics.
Ventilator-associated pneumonia: gearing towards shorter-course therapy. [2006]The studies that are reviewed in this article have all concluded that a shorter duration of antibiotic therapy (7-8 days) may be adequate in the treatment of the majority of patients with ventilator-associated pneumonia, and does not confer an increased incidence of mortality.
Duration of therapy of ventilator-associated pneumonia. [2016]Ventilator-associated pneumonia (VAP) is a major cause of morbidity and mortality in the critical care setting. It incurs great additional cost and the antibiotics prescribed for patients with VAP account for the majority of total antibiotic prescriptions. The increased cost of VAP as well as the emergence of antimicrobial resistance and the potential adverse events because of treatment indicate that the application of shorter antibiotic regimens for the treatment of VAP poses as a one-way choice.
Impact of appropriateness of initial antibiotic therapy on the outcome of ventilator-associated pneumonia. [2022]To evaluate the impact of appropriate initial antibiotic therapy (AB) on the outcome of ventilator-associated pneumonia (VAP).
Antibiotics for ventilator-associated pneumonia. [2023]Ventilator-associated pneumonia (VAP) is a significant cause of morbidity and mortality, complicating the medical course of approximately 10% of mechanically-ventilated patients, with an estimated attributable mortality of 13%. To treat VAP empirically, the American Thoracic Society currently recommends antibiotic therapy based on the patients' risk of colonisation by an organism with multidrug resistance. The selection of initial antibiotic therapy in VAP is important, as inappropriate initial antimicrobial treatment is associated with higher mortality and longer hospital stay in intensive care unit (ICU) patients.While guidelines exist for the antibiotic treatment of hospital-acquired pneumonia (HAP) from the American Thoracic Society and the British Society for Antimicrobial Chemotherapy, there are many limitations in the quality of available evidence. This systematic review aimed to summarise the results of all randomised controlled trials (RCTs) that compare empirical antibiotic regimens for VAP.
Use of quantitative cultures and reduced duration of antibiotic regimens for patients with ventilator-associated pneumonia to decrease resistance in the intensive care unit. [2007]Ventilator-associated pneumonia is responsible for approximately half of the infections acquired in the intensive care unit and represents one of the principal reasons for the prescription of antibiotics in this setting. Invasive diagnostic methods, including bronchoalveolar lavage and/or protected specimen bronchial brushing, could improve the identification of patients with true bacterial pneumonia and facilitate decisions of whether to treat. These techniques also permit rapid optimization of the choice of antibiotics in patients with proven bacterial infection, once the results of respiratory tract cultures become available, based on the identity of the specific pathogens and their susceptibility to specific antibiotics, to avoid prolonged use of a broader spectrum of antibiotic therapy than is justified by the available information. Because unnecessary prolongation of antibiotic therapy for patients with true bacterial infection may lead to the selection of multidrug-resistant microorganisms without improving clinical outcome, efforts to reduce the duration of therapy for nosocomial infections are also warranted. An 8-day regimen can probably be standard for patients with ventilator-associated pneumonia. Possible exceptions to this recommendation include immunosuppressed patients, patients who are bacteremic or whose initial antibiotic therapy was not appropriate for the causative microorganism(s), and patients whose infection is with very difficult-to-treat microorganisms and show no improvement in clinical signs of infection.
Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a randomised clinical trial. [2021]Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The "REducinG Antibiotic tReatment Duration for Ventilator-Associated Pneumonia" (REGARD-VAP) trial aims to provide evidence for using a set of reproducible clinical criteria to shorten antibiotic duration for individualised treatment duration of VAP.