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
About this trial
This is an interventional treatment trial for Ventilator-associated Pneumonia focused on measuring VAP, Critical care, Pharmacokinetics, Gentamicin
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
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
NCT ID
NCT02515448
First Posted
July 24, 2015
Last Updated
March 23, 2017
Sponsor
Poitiers University Hospital
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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