Related Experiment Video
Updated: Nov 5, 2025
Antibiotic Efficacy Testing in an Ex vivo Model of Pseudomonas aeruginosa and Staphylococcus aureus Biofilms in the Cystic Fibrosis Lung
Published on: January 22, 2021
Reducing antibiotic treatment duration for ventilator-associated pneumonia (REGARD-VAP): a trial protocol for a
Yin Mo1,2,3,4, Timothy Eoin West5,6, Graeme MacLaren7
1Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK yin_mo@nuhs.edu.sg.
Introduction:
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection in intensive care units (ICUs). Using short-course antibiotics to treat VAP caused by Gram-negative non-fermenting bacteria has been reported to be associated with excess pneumonia recurrences. The "REducinG Antibiotic tReatment Duration for Ventilator-Associated Pneumonia" (REGARD-VAP) trial aims to provide evidence for using a set of reproducible clinical criteria to shorten antibiotic duration for individualised treatment duration of VAP.
Methods And Analysis:
This is a randomised controlled hierarchical non-inferiority-superiority trial being conducted in ICUs across Nepal, Thailand and Singapore. The primary outcome is a composite endpoint of death and pneumonia recurrence at day 60. Secondary outcomes include ventilator-associated events, multidrug-resistant organism infection or colonisation, total duration of antibiotic exposure, mechanical ventilation and hospitalisation. Adult patients who satisfy the US Centers for Disease Control and Prevention National Healthcare Safety Network VAP diagnostic criteria are enrolled. Participants are assessed daily until fever subsides for >48 hours and have stable blood pressure, then randomised to a short duration treatment strategy or a standard-of-care duration arm. Antibiotics may be stopped as early as day 3 if respiratory cultures are negative, and day 5 if respiratory cultures are positive in the short-course arm. Participants receiving standard-of-care will receive antibiotics for at least 8 days. Study participants are followed for 60 days after enrolment. An estimated 460 patients will be required to achieve 80% power to determine non-inferiority with a margin of 12%. All outcomes are compared by absolute risk differences. The conclusion of non-inferiority, and subsequently superiority, will be based on unadjusted and adjusted analyses in both the intention-to-treat and per-protocol populations.
Ethics And Dissemination:
The study has received approvals from the Oxford Tropical Research Ethics Committee and the respective study sites. Results will be disseminated to patients, their caregivers, physicians, the funders, the critical care societies and other researchers.
Trial Registration Number:
NCT03382548.
Insights
The REGARD-VAP trial investigates shortening antibiotic treatment for ventilator-associated pneumonia (VAP). This approach aims to reduce recurrences while maintaining patient safety in intensive care units (ICUs).
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Clinical Trials
Background:
- Ventilator-associated pneumonia (VAP) is a leading nosocomial infection in intensive care units (ICUs).
- Short-course antibiotics for Gram-negative non-fermenting bacteria VAP are linked to increased recurrence rates.
- The REGARD-VAP trial addresses the need for evidence-based criteria to individualize VAP antibiotic treatment duration.
Purpose of the Study:
- To evaluate a strategy of shortening antibiotic duration for VAP based on clinical criteria.
- To determine if a shorter antibiotic course is non-inferior, and potentially superior, to standard care regarding VAP recurrence and mortality.
- To provide evidence for reproducible clinical criteria to guide individualized VAP treatment.
Main Methods:
- A randomized controlled trial (REGARD-VAP) conducted in ICUs across Nepal, Thailand, and Singapore.
- Adult patients meeting CDC VAP criteria randomized to short-duration (as early as day 3-5) or standard-of-care (≥8 days) antibiotic treatment.
- Primary outcome: composite of death and VAP recurrence at 60 days; secondary outcomes include VAEs, MDROs, and duration of ventilation/hospitalization.
Main Results:
- The trial is designed to enroll 460 patients to achieve 80% power for non-inferiority testing.
- Primary outcome analysis will compare absolute risk differences between treatment arms.
- Both intention-to-treat and per-protocol analyses will be conducted to assess non-inferiority and superiority.
Conclusions:
- The REGARD-VAP trial will provide crucial evidence on optimizing antibiotic duration for VAP.
- Findings will inform clinical practice guidelines for managing VAP, potentially reducing antibiotic exposure and resistance.
- The study aims to establish safe and effective criteria for individualized VAP treatment strategies.
More Related Videos
04:32Murine Oropharyngeal Aspiration Model of Ventilator-associated and Hospital-acquired Bacterial Pneumonia
Published on: June 28, 2018
09:17A Robust Pneumonia Model in Immunocompetent Rodents to Evaluate Antibacterial Efficacy against S. pneumoniae, H. influenzae, K. pneumoniae, P. aeruginosa or A. baumannii
Published on: January 2, 2017
Related Concept Videos
01:28Pneumonia IV: Management
Bacterial Pneumonia Treatment
For bacterial pneumonia, antibiotics serve as the cornerstone of therapy. Initial treatment often begins with empirical antibiotics, tailored to the anticipated causative organism and adjusted based on culture results. Key antibiotic choices include:
01:30Pneumonia V: Nursing management and Prevention
The nurse must practice strict medical asepsis and adhere to infection control guidelines to minimize healthcare-associated infections.
Enhance airway patency
Position the patient correctly to facilitate drainage of the affected lung segments. Manual or mechanical percussion and vibration can also be employed....
01:28Pulmonary Tuberculosis V
Latent tuberculosis infection occurs when TB bacteria are present in a person's body, but are not causing illness or symptoms. It is not contagious, and preventive treatment is crucial to avoid the...
01:29Acute Respiratory Failure-V
Ensure that patients are monitored continuously for their response to therapy, including changes in...
01:30Pneumonia I: Introduction
Risk Factors
Various factors influence the likelihood of developing pneumonia. Age plays a crucial role, with infants, children under two, and individuals over 65 at increased risk due to their...