Inhaled Amikacin Versus Placebo in Patients With Ventilator-associated Tracheobronchitis
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
The primary objective of the AMIVAT trial is to assess whether a 5-day course of inhaled amikacin, compared to placebo, reduces the incidence of progression to ventilator-associated pneumonia (VAP) at day 28 in intensive care unit (ICU) patients with ventilator-associated tracheobronchitis (VAT). Transition from VAT to VAP will be defined as the occurrence of a first VAP episode due to the same pathogens than those responsible for VAT.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Admission to a participating intensive care unit (ICU)
Invasive mechanical ventilation > 48 hours
First episode of ventilator-associated tracheobronchitis during the ICU stay defined using the following criteria: (i) purulent tracheobronchial secretions, (iii) no new or progressive persistent pulmonary infiltrate on chest X-ray, and (iv) bacterial growth on endotracheal aspirate ≥10.5 colony-forming unit (CFU)/mL or on bronchoalveolar lavage ≥10.4 CFU/mL or on plugging telescopic catheter ≥10.3 CFU/mL
Disqualifiers
Previous ventilator-associated pneumonia due to the pathogens responsible for ventilator-associated tracheobronchitis during the same ICU stay
On-going antimicrobial therapy fpr ventilator-associated pneumonia
Ventilator-associated tracheobronchitis due to pathogens with intrinsic amikacin resistance (e.g. Stenotrophomonas maltophilia)
On-going therapy with intravenous amikacin or another aminoglycoside
Trial design
Treatments tested in this trial
- Optimized and protocolized nebulization procedure.
- Optimized and protocolized nebulization procedure.
Treatment groups
250 Participants
are divided into 2 treatment groupsLocations
1706 - ANGERS - Intensive care, University Hospital49933, Angers France
04 - ARGENTEUIL - Intensive care, University Hospital Argenteuil France
11 - BLOIS, Intensive care, Hospital Blois France
09 - BOURG-EN-BRESSE, Intensive care, Hospital01012, Bourg-en-Bresse France
Sponsors and collaborators
University Hospital, Tours
Lead sponsor
Aerogen
Collaborator
Source ClinicalTrials.gov