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

Ventilator-associated Pneumonia Clinical Trial

— GENTAERO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515448
• Other study ID #: GENTAERO
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2015
• Last updated: March 23, 2017
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: May 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

Intervention

Drug:
• gentamicin

Locations

Country	Name	City	State
France	BOISSON Matthieu	Poitiers
France	Dequin P-F	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Peak Plasma Concentration (Cmax)"		3 days
Secondary	PaO2/FiO2 ratio deterioration above 20%.	Bronchodilators used.	3 days