Duration of Antibiotic Treatment for Early VAP (DATE) Trial (DATE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01994980|
Recruitment Status : Suspended (Pending IRB continuing review approval.)
First Posted : November 26, 2013
Last Update Posted : August 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Early Ventilator Associated Pneumonia||Drug: Default 4 days antibiotic therapy||Not Applicable|
The prevalence of multi-drug resistant (MDR) pathogens in intensive care units (ICUs) worldwide has reached epidemic proportions. In some cases, the choice of potential therapy is limited or even non-existent. Antibiotic prescription, through selection pressure, represents the main mechanism by which resistance emerges. Limitations in the development of new antibiotics underscores the importance of adherence to the principles of antibiotic stewardship.
Ventilator associated pneumonia (VAP) is the most common serious infection in mechanically ventilated, critically ill patients. Approximately one half of antibiotic prescription in the ICU is related to VAP, including prophylactic, empiric, and definitive therapy. The development of evidence-based algorithms for the rational use of antibiotics in the management of patients with both suspected and confirmed VAP is pivotal to decreasing the emergence of MDR pathogens.
Shortening the duration of antimicrobial therapy for VAP represents one strategy to curtail the emergence of MDR pathogens. Although current guidelines recommend a treatment course of 8-14 days, both clinical and microbiologic resolution (MR) of infection typically occur much sooner [10, 11]. In one study of ICU patients ventilated for > 5 days who developed VAP, 8 days of antimicrobial therapy was equally as effective as 14 days, provided VAP was not caused by a non-lactose fermenting gram negative bacillus. Favorable results following shorter courses of therapy for VAP have been observed, albeit in small, uncontrolled series.
One subset of patients for whom a decreased duration of antimicrobial therapy may be particularly effective is those who develop VAP ≤ 5 days after intubation (early VAP). Early VAP comprises approximately one half of cases of pneumonia diagnosed in the ICU. Furthermore, as compared to patients who develop late VAP, patients who develop early VAP are more likely to be infected with community-acquired pathogens sensitive to narrow spectrum antibiotics. Finally, nearly all cases of early VAP caused by sensitive pathogens demonstrate MR after relatively short (3-5 days) courses of therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial of 4 vs. 8 Days of Definitive Antibiotic Therapy for Early Ventilator-Associated Pneumonia in the Surgical Intensive Care Unit|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 2025|
Active Comparator: Default 4 days antibiotic therapy
Default 4 days antibiotic therapy
Drug: Default 4 days antibiotic therapy
The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.
Other Name: Antibiotic for 4 days
No Intervention: Default 8 days antibiotic therapy
Default 8 days antibiotic therapy
- Clinical Response [ Time Frame: Daily for 28 days ]CPIS score
- Biomarker response [ Time Frame: Daily for either 4 or 8 days, dependent upon treatment arm ]Procalcitonin
- Microbiologic response [ Time Frame: 1 Day after last day of treatment ]BAP culture <10^3 cfu/mL
- Infection with MDR pathogen [ Time Frame: 28 days ]The patient has growth of a multidrug resistant pathogen on culture
- Recurrence [ Time Frame: 28 days ]The patient has another occurrence of VAP after treatment
- Ventilator free days [ Time Frame: 28 days ]The number of day the patient does need mechanical ventilation
- Mortality [ Time Frame: 28 days ]The patient has died
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994980
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Fredric Pieracci, MD MPH||Denver Health and Hospital|