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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02515448
Acronym
GENTAERO
Enrollment
12
Registered
2015-08-04
Start date
2015-10-31
Completion date
2017-01-31
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator-associated Pneumonia

Keywords

VAP, Critical care, Pharmacokinetics, Gentamicin

Brief 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.

Interventions

DRUGgentamicin

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Peak Plasma Concentration (Cmax)3 days

Secondary

MeasureTime frameDescription
PaO2/FiO2 ratio deterioration above 20%.3 daysBronchodilators used.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026