The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days

University of Miami

Status and phase: Terminated; Phase 4

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: Standard of Care Antibiotic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05545735

20211211

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Surgical patient
2. Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
3. Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
4. Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)

Exclusion criteria

1. Age < 18 years

2. Prior episode of VAP for the index admission

3. VAP caused by any of the following pathogens:

   • Methicillin-resistant Staphylococcus aureus (MRSA)
   • Vancomycin-intermediate Staphylococcus aureus (VISA)
   • Pseudomonas aeruginosa
   • Vancomycin-resistant Enterococcus (VRE)
   • Acinetobacter baumanii
   • Stenotrophomonas maltophilia
   • Carbapenem-resistant Enterobacteriaceae (CRE)
   • Extended-spectrum beta lactamase-producing gram-negative bacilli

4. Causative pathogen not sensitive to choice of initial empiric antibiotic

5. Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis

6. Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring > 1 vasopressor (17)

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

8. LOS > 72 hours at a transferring facility

9. Pregnancy or lactation

10. Legal arrest or incarceration

11. Moribund state in which death is imminent

12. ECMO (Extracorporeal membrane oxygenation)

13. Extubation prior to randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

4 Days of Antibiotics Group

Experimental group

Description:

Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).

Treatment:

Drug: Standard of Care Antibiotic Therapy

7 Days of Antibiotics Group

Active Comparator group

Description:

Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).

Treatment:

Drug: Standard of Care Antibiotic Therapy