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REGARD-VAP

REGARD-VAP

THE LANCET: Respiratory Medicine

January 22, 2024

Individualized, short-course antibiotic treatment versus usual long-course treatment for ventilator-associated pneumonia.

Mazen Kherallah

Summarized by: 

The study was a phase 4, randomized, open-label trial conducted in 39 ICUs across Nepal, Singapore, and Thailand. It used a non-inferiority–superiority framework with patients assigned 1:1 to groups using stratified permuted blocks. Blinding was partial, with assessors and participants unaware of treatment allocation, but not clinicians. The non-inferiority margin was set at 12%, and analyses included both intention-to-treat and per-protocol populations.



Population:

  • Adults (age ≥18 years) with ventilator-associated pneumonia (VAP), mechanically ventilated for ≥48 hours, administered culture-directed antibiotics.

  • 461 patients (232 in the short-course group, 229 in the usual care group).

  • Median age 64 years; 39% female.


Intervention:

  • Individualized short-course antibiotic treatment for VAP.

  • DUration of antibiotics: ≤7 days, potentially as short as 3–5 days.


Comparison:

  • Usual care for VAP.

  • Duration of antibiotics ≥8 days, determined by primary clinicians.


Outcome:

  • Primary Outcome: 60-day composite of death or pneumonia recurrence.

  • Intention-to-Treat Analysis (460 patients): Short-course Group: 41% met the primary outcome; median antibiotic duration was 6 days (IQR 5–7 days). Usual Care Group: 44% met the primary outcome; median antibiotic duration was 14 days (IQR 10–21 days).

  • Per-Protocol Population (435 participants): Similar results as intention-to-treat, confirming non-inferiority.

  • Antibiotic Side-Effects: Significantly lower in the short-course group (8%) versus the usual care group (38%).

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