AMIKINHAL (AMIKACIN inhaled)

Phase 1

• Conditions: Patient with mechanical ventilation through an endotracheal tube; MedDRA version: 19.1Level: LLTClassification code 10065153Term: Ventilator associated pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-001054-17-FR
• Lead Sponsor: CHRU de Tours

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-05
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 850

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified