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

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.

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Key information

Conditions

Ventilator-associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BOISSON Matthieu, Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gentamicin

Drug

Primary outcomes

"Peak Plasma Concentration (Cmax)"

Time frame: 3 days

Secondary outcomes

PaO2/FiO2 ratio deterioration above 20%.

Time frame: 3 days

Bronchodilators used.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: GENTAERO

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Aug 4, 2015
Registry last updated: Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed