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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

Information source: Poitiers University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ventilator-associated Pneumonia

Intervention: gentamicin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Poitiers University Hospital


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.

Clinical Details

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: "Peak Plasma Concentration (Cmax)"

Secondary outcome: PaO2/FiO2 ratio deterioration above 20%.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Dequin P-F, Tours 37000, France
Additional Information

Last updated: August 3, 2015

Page last updated: August 23, 2015

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