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
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.
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%.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dequin P-F, Tours 37000, France
Additional Information
Last updated: August 3, 2015
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