AMIKINHAL (AMIKACIN inhaled)

Double-blinded multicenter randomized controlled trial comparing inhaled amikacin versus placebo to prevent ventilator associated pneumonia - AMIKINHAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001054-17-FR

Enrollment

850

Registered

2017-05-05

Start date

2017-01-27

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient with mechanical ventilation through an endotracheal tube MedDRA version: 19.1 Level: LLT Classification code 10065153 Term: Ventilator associated pneumonia System Organ Class: 100000004862

Interventions

Trade Name: AMIKACIN 1 g, powder for nebulization Product Name: AMIKACIN Pharmaceutical Form: Powder for nebuliser solution Pharmaceutical form of the placebo: Nebuliser solution Route of administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years the day of inclusion - Mechanical ventilation through an endotracheal tube for more than three consecutive days (72h) - Written informed consent of the patient or a proxy - Patients covered by or having the rights to French social security Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 600 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: - Suspicion or confirmed VAP - Clinical indication for systemic aminoglycoside therapy - Stage 3 KDIGO classification acute kidney injury excepted in patients undergoing renal replacement therapy - Patient scheduled for extubation within the next 24h - Patient ventilated more than 4 days before inclusion (96h) - Patient ventilated through a tracheostomy - Patients allergic to aminoglycosides - Myasthenia gravis - Pregnant or lactating patients - Patients undergoing guardianship or trusteeship - Patients previously included in this study

Design outcomes

Primary

Measure	Time frame
Main Objective: To prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP;Timepoint(s) of evaluation of this end point: Day 28;Secondary Objective: To prove that a three-day course of inhaled amikacin reduces the incidence of subsequent VAP in the subgroup of patients with tracheobronchial bacterial colonization and with tracheobronchitis at randomization, subsequent VAP due to Gram negative bacteria sensitive to amikacin,clinical signs of tracheobronchial and lung infection, reduces the subsequent use of systemic antibiotics, the length of stay in the intensive care unit and in the hospital and intensive care unit, hospital, day28 and day90 mortality, speeds up weaning from mechanical ventilation and is not associated with an increased incidence of acute kidney injury. To assess the impact on the incidence of antibiotic-resistant bacteria nosocomial infection and rectal carriage of antibiotic resistant bacteria and the respiratory and digestive microbiota composition over a subsample of included patients. To assess pharmacokinetics of inhaled amikacin in a large multicenter sample over a subsample of included patients. ;Primary end point(s): Incidence of a first VAP episode from randomization to day 28: diagnosis will be standardized : two criteria among hyperleukocytosis/leukopenia, fever, purulent secretion with a new chest X-ray infiltrate and significant bacterial growth in a pulmonary sample. Outcome will be adjudicated by a blinded committee at study end.	—

Measure

Time frame

Main Objective: To prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP;Timepoint(s) of evaluation of this end point: Day 28;Secondary Objective: To prove that a three-day course of inhaled amikacin reduces the incidence of subsequent VAP in the subgroup of patients with tracheobronchial bacterial colonization and with tracheobronchitis at randomization, subsequent VAP due to Gram negative bacteria sensitive to amikacin,clinical signs of tracheobronchial and lung infection, reduces the subsequent use of systemic antibiotics, the length of stay in the intensive care unit and in the hospital and intensive care unit, hospital, day28 and day90 mortality, speeds up weaning from mechanical ventilation and is not associated with an increased incidence of acute kidney injury. To assess the impact on the incidence of antibiotic-resistant bacteria nosocomial infection and rectal carriage of antibiotic resistant bacteria and the respiratory and digestive microbiota composition over a subsample of included patients. To assess pharmacokinetics of inhaled amikacin in a large multicenter sample over a subsample of included patients. ;Primary end point(s): Incidence of a first VAP episode from randomization to day 28: diagnosis will be standardized : two criteria among hyperleukocytosis/leukopenia, fever, purulent secretion with a new chest X-ray infiltrate and significant bacterial growth in a pulmonary sample. Outcome will be adjudicated by a blinded committee at study end.

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Secondary

Measure	Time frame
Secondary end point(s): From randomization to day 28: - Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis at randomization Incidence of VAP due to Gram negative amikacin sensitive bacteria - Clinical pulmonary infection score evolution - Ventilator associated events incidence - Number of systemic antibiotics administered per day - Number of days with at least one administration of a systemic antibiotic - Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples - Incidence of acute kidney injury - Days spent on mechanical ventilation from randomization to day 90 - Days from randomization to the first successful spontaneous breathing trial - Days spent in the intensive care unit and in the hospital after randomization - Intensive care unit, hospital, day-28 and day-90 mortality - Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples at discharge compared to randomization - Relative bacterial species composition of respiratory and digestive microbiota - Sputum and serum amikacin population pharmacokinetics - Respiratory mechanics before and after aerosol ;Timepoint(s) of evaluation of this end point: randomization to day 28, at the end of ICU-stay, day 28, day 90	—

Measure

Time frame

Secondary end point(s): From randomization to day 28: - Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis at randomization Incidence of VAP due to Gram negative amikacin sensitive bacteria - Clinical pulmonary infection score evolution - Ventilator associated events incidence - Number of systemic antibiotics administered per day - Number of days with at least one administration of a systemic antibiotic - Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples - Incidence of acute kidney injury - Days spent on mechanical ventilation from randomization to day 90 - Days from randomization to the first successful spontaneous breathing trial - Days spent in the intensive care unit and in the hospital after randomization - Intensive care unit, hospital, day-28 and day-90 mortality - Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples at discharge compared to randomization - Relative bacterial species composition of respiratory and digestive microbiota - Sputum and serum amikacin population pharmacokinetics - Respiratory mechanics before and after aerosol ;Timepoint(s) of evaluation of this end point: randomization to day 28, at the end of ICU-stay, day 28, day 90

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Countries

France

Contacts

Public ContactClinical research Associate

CHRU de Tours

marie.leclerc@univ-tours.fr0247474664

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026