Duration of Antibiotic Treatment for Early VAP (DATE) Trial

NCT01994980 | Completed Results DMC

• 1 other identifier: 13-0205
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: 4 days of antibiotic therapy, as compared to 8 days, is equally effective and results in decreased antibiotic exposure among surgical ICU patients with early VAP.

Conditions

Early Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Clinical Response

  Clinical Pulmonary Infection Score (CPIS) score. Scales of this score include Temperature, Blood Leukocytes, Tracheal Secretions, Oxygenation, Pulmonary Radiography, and Culture of Tracheal Aspirate. Each scale can have sub-scores ranging from 0-2, with a total CPIS score ranging from 0-12. In this outcome measure, higher scores mean worse functioning and risk for worse outcomes. Scores for the patients analyzed on this outcome measure were taken daily for 28 days and then averaged across that time point.

  Daily for 28 days

Study Arms (2)

Default 4 days antibiotic therapy

ACTIVE COMPARATOR

Default 4 days antibiotic therapy

Drug: Default 4 days antibiotic therapy

Default 8 days antibiotic therapy

NO INTERVENTION

Default 8 days antibiotic therapy

Interventions

Default 4 days antibiotic therapy DRUG

The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.

Also known as: Antibiotic for 4 days

Default 4 days antibiotic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical patient
• VAP, defined as clinical suspicion plus a bronchoalveolar lavage (BAL) culture showing ≥105 cfu/mL of at least one pathogen. The quantitative microbiology threshold will be lowered to ≥104 cfu/mL if the patient was being treated with antibiotics to which the pathogen is sensitive at the time of the BAL. Clinical suspicion of VAP is defined as at least one point for ≥ 2 variables in the Clinical Pulmonary Infection Score (CPIS, described below).
• Ventilated ≤ 5 days at the time that the BAL was obtained.
• Hospital LOS ≤ 5 days at the time that the BAL was obtained.

You may not qualify if:

• Age \< 18 years.
• Prior episode of VAP for the index admission (the patient may have had prior BALs sent for culture, but these cannot have met the above mentioned diagnostic criteria for VAP).
• VAP caused by a MDR pathogen: Early VAP is rarely caused by a MDR pathogen; in a recent analysis of our surgical ICU, 94% of cases of early VAP were caused by a highly sensitive pathogen (MSSA 39%, H flu 35%, S. pneumo 16%, E. coli 9%) (Pieracci in press). Patients with early VAP caused by the following MDR pathogens will be excluded: Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-intermediate Staphylococcus aureus (VISA), pseudomonas aeruginosa, Vancomycin-resistant enterococcus (VRE), Acinetobacter baumannii, Stenotrophomonas maltophilia, and extended-spectrum beta lactamase producing gram negative bacilli.
• Antibiotic therapy for ≥ 5 of the last 10 days preceding the BAL.
• Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring ≥ 1 vasopressor.
• Current or recent (within 30 days) use of immunosuppressive medications.
• Length of stay ≥ 48 hours in a transferring facility.
• Inpatient hospitalization within 30 days of admission.
• Pregnancy or lactation.
• Legal arrest or incarceration.
• Moribund state in which death is imminent.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Anti-Infective Agents; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr Fredric Pieracci
• Organization: Denver Health

Fredric.Pieracci@dhha.org

303-436-4029

Study Officials

• Fredric Pieracci, MD MPH

  Denver Health and Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 26, 2013
• Study Start: December 1, 2013
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-12

Locations

US (1)