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Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre
Elsa Tavernier1, Francois Barbier2, Ferhat Meziani3
1Inserm CIC 1415, CHRU Tours, Tours, France.
Introduction:
Pre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.
Methods And Analysis:
Academic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasively ventilated more than 3 days will be randomised to receive 20 mg/kg inhaled amikacin daily for 3 days or inhaled placebo (0.9% Sodium Chloride). Occurrence of ventilator-associated pneumonia will be recorded based on a standardised diagnostic framework from randomisation to day 28 and adjudicated by a centralised blinded committee.
Ethics And Dissemination:
The protocol and amendments have been approved by the regional ethics review board and French competent authorities (Comité de protection des personnes Ouest I, No.2016-R29). All patients will be included after informed consent according to French law. Results will be disseminated in international scientific journals.
Trial Registration Numbers:
EudraCT 2016-001054-17 and NCT03149640.
Insights
Pre-emptive inhaled antibiotics, given for three days, may reduce ventilator-associated pneumonia in critically ill patients. This approach also shows promise in lowering antibiotic resistance, a significant clinical concern.
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Pulmonology
Background:
- Ventilator-associated pneumonia (VAP) is a common complication in critically ill patients requiring invasive mechanical ventilation.
- Existing meta-analyses suggest a potential benefit of pre-emptive inhaled antibiotics in reducing VAP occurrence.
- Inhaled antibiotics may also mitigate the emergence of antibiotic-resistant bacteria.
Purpose of the Study:
- To evaluate the efficacy of a 3-day course of inhaled antibiotics in preventing ventilator-associated pneumonia.
- To assess the impact of inhaled amikacin on VAP occurrence in patients on invasive mechanical ventilation for over 3 days.
Main Methods:
- A multicentre, double-blind, randomized controlled superiority trial.
- Patients invasively ventilated for >3 days were randomized to receive daily inhaled amikacin (20 mg/kg) or placebo for 3 days.
- VAP occurrence was monitored from randomization to day 28 and adjudicated by a blinded committee.
Main Results:
- Data on main results are not yet available as this is a protocol description.
Conclusions:
- The study aims to provide robust evidence on the effectiveness of inhaled antibiotics for VAP prevention.
- Findings could inform clinical guidelines for managing mechanically ventilated patients.
- The trial may contribute to strategies for combating antibiotic resistance in intensive care settings.
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