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)

Poitiers University Hospital

Status and phase: Completed; Phase 1

Conditions: Ventilator-associated Pneumonia

Treatments: Drug: gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02515448

GENTAERO

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Gentamicine injectable(day 1+2)and then gentamicine inhalation

Experimental group

Treatment:

Drug: gentamicin