Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia (AMIKINHAL)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Pneumonia, Ventilator-Associated

Treatments: Drug: Inhaled amikacin; Drug: Inhaled placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03149640

PHRN15-SE / AMIKINHAL

Details and patient eligibility

About

The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.

Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

Enrollment: 850 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Negative pregnancy test, at the time of inclusion, in women of childbearing potential

Exclusion criteria

• Suspicion or confirmed VAP the day of inclusion
• Clinical indication for systemic aminoglycoside therapy the day of inclusion : as deemed necessary by the clinician in charge
• Stage 2 or 3 KDIGO* classification acute kidney injury the day of inclusion excepted in patients undergoing renal replacement therapy
• Chronic kidney failure : baseline glomerular filtration lower than 30 mL/min
• Patient scheduled for extubation within the next 24h
• Patient ventilated through an endotracheal tube for more than four consecutive days before inclusion (96h)
• Patient ventilated through a tracheostomy
• Patients allergic to aminoglycosides
• Myasthenia gravis
• Known pregnant women at the time of inclusion and lactating patients
• Known guardianship or trusteeship at the time of inclusion
• Patients previously included in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 2 patient groups, including a placebo group

Inhaled amikacin

Experimental group

Description:

Inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.

Treatment:

Drug: Inhaled amikacin

Placebo

Placebo Comparator group

Description:

Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.

Treatment:

Drug: Inhaled placebo