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 | Completed Phase 1

• 1 other identifier: GENTAERO
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventilator-associated Pneumonia

Keywords

VAP; Critical care; Pharmacokinetics; Gentamicin

Outcome Measures

Primary Outcomes (1)

• "Peak Plasma Concentration (Cmax)"

  3 days

Secondary Outcomes (1)

• PaO2/FiO2 ratio deterioration above 20%.

  3 days

Study Arms (1)

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

EXPERIMENTAL

Drug: gentamicin

Interventions

gentamicin DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (2)

BOISSON Matthieu

Poitiers, France, 86021, France

Location

Dequin P-F

Tours, France, 37000, France

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: August 4, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2017
• Last Updated: March 24, 2017

Record last verified: 2016-05

Locations

FR (2)