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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Optimized and protocolized nebulization procedure.
DrugPatients in the experimental group will receive inhaled amikacin (once daily, 20 mg/kg of predicted body weight with a maximum of 2 grams) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
Optimized and protocolized nebulization procedure.
DrugPatients in the control group will receive inhaled placebo (NaCl 0.9%, once daily) from Day 1 (inclusion, randomization and first nebulization) to Day 5 through an optimized and protocolized nebulization procedure (vibrating mesh nebulizer).
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Inhaled amikacinExperimental treatment 1 intervention
Group B: Inhaled NaCl 0.9%Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 28
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
Time frame
From randomization to day 28Secondary outcomes
1
Incidence of transition from ventilator-associated tracheobronchitis to ventilator-associated pneumonia at day 7
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
Time frame
From randomization to day 72
Overall incidence of a first ventilator-associated pneumonia episode (all pathogens) at day 28
Time frame
From randomization to day 283
Overall incidence of a first ventilator-associated pneumonia episode due to multidrug-resistant bacteria at day 28
Time frame
From randomization to day 284
Time to resolution of clinical signs of ventilator-associated tracheobronchitis
Purulent tracheal aspirates, plus leukocytosis or leukopenia and/or fever or hypothermia if present at randomization
Time frame
From randomization to day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Tours
Lead sponsor
Aerogen
Collaborator
Source ClinicalTrials.gov
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