drugset / Trial / NCT02515448

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

NCT02515448

Phase 1 Completed 12 enrolled Poitiers University Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-10
Primary completion
2016-11
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Gentamicin Small molecule 8 mg/kg Inhaled

Indications

No indication recorded.