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Completed

NCT Number: NCT03149640

Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

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.

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Key information

Conditions

Pneumonia, Ventilator-Associated Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de Réanimation Chirurgicale, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhaled amikacin

Drug

Once a day, 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.

Inhaled placebo

Drug

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

Primary outcomes

  1. Incidence of a first VAP episode from randomization to day 28

    Time frame: Patients will be followed from randomization to day 28

Secondary outcomes

  1. Incidence of a first VAP episode in the subgroups of patients with tracheobronchial colonization or tracheobronchitis

    Time frame: At randomization

  2. Incidence of VAP due to Gram negative amikacin sensitive bacteria

    Time frame: Patients will be followed from randomization to day 28

  3. Clinical pulmonary infection score evolution

    Time frame: Patients will be followed from randomization to day 28

  4. Ventilator associated events incidence

    Time frame: Patients will be followed from randomization to day 28

  5. Number of systemic antibiotics administered per day

    Time frame: Patients will be followed from randomization to day 28

  6. Number of days with at least one administration of a systemic antibiotic

    Time frame: Patients will be followed from randomization to day 28

  7. Incidence of antibiotic resistant bacteria isolated on clinical and hygiene samples

    Time frame: Patients will be followed from randomization to day 28

  8. Incidence of acute kidney injury

    Time frame: Patients will be followed from randomization to day 28

  9. Days spent on mechanical ventilation from randomization to day 90

    Time frame: Patients will be followed from randomization to day 90

  10. Days from randomization to the first successful spontaneous breathing trial

    Time frame: Days from randomization to day 90 max

  11. Days spent in the intensive care unit and in the hospital

    Time frame: Patients will be followed from randomization to discharge (day 90 max)

  12. Day 90 mortality

    Time frame: Day 90

  13. Incidence of bacteria producing extended spectrum beta-lactamase or high level derepressed celphalosporinase, of vancomycin resistant Enterococcus Sp. on rectal samples

    Time frame: Day 28

  14. Relative bacterial species composition of respiratory and digestive microbiota

    Time frame: Patients will be followed from randomization to day 28

  15. Maximum serum Concentration

    Time frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24

  16. Maximum sputum Concentration

    Time frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24

  17. Area Under the Curve

    Time frame: Between Hour 0-Hour 8, between Hour 8-Hour 16 and between Hour 16-Hour 24

  18. To evaluate the effects on respiratory mechanics of nebulization of amikacin by evaluating the benefit balance / risk

    Time frame: Measurements at 8 hours, 12 hours and 24 hours after the end of nebulization

    benefit : Improvement of respiratory mechanics by pharmacological effect risk : Degradation of respiratory mechanics by bronchospastic secondary effect, drug deposition in the intubation probe

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

Acronym: AMIKINHAL

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 11, 2017
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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