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Antibiotic

Shortened Antibiotic Therapy for Ventilator-Associated Pneumonia (DATE Trial)

Phase 4

Recruiting

Led By Jonathan Meizoso, MD, MSPH

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Surgical patient

Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis

Must not have

LOS > 72 hours at a transferring facility

VAP caused by specific 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, Causative pathogen not sensitive to choice of initial empiric antibiotic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will test if lowering the amount of antibiotics given for ventilator-associated pneumonia can reduce side effects, while still keeping patients safe.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical adverse reactions associated with antibiotics such as allergic reactions, gastrointestinal issues like nausea and diarrhea, potential development of drug-resistant bacteria due to overuse of antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for or have had surgery.

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I was in the hospital for less than 10 days when diagnosed with VAP.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was hospitalized for more than 72 hours before being transferred.

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My lung infection is caused by a drug-resistant bacteria.

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I have septic shock and need more than one medication to maintain my blood pressure.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antibiotics

Number of participants with reoccurring VAP

Secondary study objectives

Amount of antibiotic exposure

Clinical improvement as measured by the Clinical Pulmonary Infection Score

Hospital Length Of Stay

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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).

0 / 6Eligibility criteria met