A Pharmacokinetic-pharmacodynamic Dose Comparison Study of 8 mg/kg of Inhaled or Parenteral Gentamicin in 12 Mechanically Ventilated Critically Ill Patients Treated for Ventilator-associated Pneumonia

Phase 1

Completed

• Conditions: Ventilator-associated Pneumonia
• Interventions: Drug: gentamicin

• Registration Number: NCT02515448
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Ventilator associated pneumonia (VAP) remains in the intensive care unit the infection associated with the highest morbidity and mortality.

Respiratory infection with resistant organism are increasing in prevalence. Because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection.

Aerosolized Amikacin or Tobramycin are used in mechanically ventilated patients for respiratory infections. Gentamicin,which is effective against numerous multi drug resistant Gram-negative organism and Gram-positive like Staphylococcus aureus, could be a great option for nebulisation.

The investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-04
• Study Start: 2015-10
• Status Verified: 2016-05
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• to be in critical care unit
• to be mechanically ventilated
• to have a ventilator-associated pneumonia requiring a treatment by gentamicin
• to be affiliated to a national insurance scheme
• to have given an informed consent (patient or close person)

Exclusion Criteria

• to be obese (BMI > 40 kg/m²)
• to have been treated by gentamicin for 7 days
• to be allergic to aminoglycoside
• to have a severe respiratory failure (PaO2 / FiO2 < 150)
• to have a renal failure (Cl creat < 60 ml/min/1.73m²)
• to be under reinforced protection measure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gentamicine injectable(day 1+2)and then gentamicine inhalation	gentamicin	-

Primary Outcome Measures

Name	Time	Method
"Peak Plasma Concentration (Cmax)"	3 days

Secondary Outcome Measures

Name	Time	Method
PaO2/FiO2 ratio deterioration above 20%.	3 days	Bronchodilators used.

Trial Locations

Locations (2)

BOISSON Matthieu; 🇫🇷 Poitiers, France

Dequin P-F; 🇫🇷 Tours, France