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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 (GENTAERO)

Primary Purpose

Ventilator-associated Pneumonia

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
gentamicin
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator-associated Pneumonia focused on measuring VAP, Critical care, Pharmacokinetics, Gentamicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BOISSON Matthieu
  • Dequin P-F

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gentamicine injectable(day 1+2)and then gentamicine inhalation

Arm Description

Outcomes

Primary Outcome Measures

"Peak Plasma Concentration (Cmax)"

Secondary Outcome Measures

PaO2/FiO2 ratio deterioration above 20%.
Bronchodilators used.

Full Information

First Posted
July 24, 2015
Last Updated
March 23, 2017
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02515448
Brief Title
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
Acronym
GENTAERO
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
VAP, Critical care, Pharmacokinetics, Gentamicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gentamicine injectable(day 1+2)and then gentamicine inhalation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gentamicin
Primary Outcome Measure Information:
Title
"Peak Plasma Concentration (Cmax)"
Time Frame
3 days
Secondary Outcome Measure Information:
Title
PaO2/FiO2 ratio deterioration above 20%.
Description
Bronchodilators used.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
BOISSON Matthieu
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Dequin P-F
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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