Duration of Antibiotic Treatment for Early VAP (DATE) Trial

• Status: Suspended
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

1. Surgical patient

2. 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).

3. Ventilated ≤ 5 days at the time that the BAL was obtained.

4. Hospital LOS ≤ 5 days at the time that the BAL was obtained.

Exclusion Criteria:

1. Age < 18 years.

2. 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).

3. 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.

4. Antibiotic therapy for ≥ 5 of the last 10 days preceding the BAL.

5. Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring ≥ 1 vasopressor.

6. Current or recent (within 30 days) use of immunosuppressive medications.

7. Length of stay ≥ 48 hours in a transferring facility.

8. Inpatient hospitalization within 30 days of admission.

9. Pregnancy or lactation.

10. Legal arrest or incarceration.

11. Moribund state in which death is imminent.

-