GENTAERO: 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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02515448
• Collaborator: (none)
• Enrollment: 12
• Locations: 2
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site: 6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator-associated Pneumonia	Drug: gentamicin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gentamicine injectable(day 1+2)and then gentamicine inhalation	Drug: gentamicin

Outcome Measures

Primary Outcome Measures

1. "Peak Plasma Concentration (Cmax)" [3 days]

Secondary Outcome Measures

1. PaO2/FiO2 ratio deterioration above 20%. [3 days]

   Bronchodilators used.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BOISSON Matthieu	Poitiers		France	86021
2	Dequin P-F	Tours		France	37000

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT02515448
• Other Study ID Numbers: GENTAERO
• First Posted: Aug 4, 2015
• Last Update Posted: Mar 24, 2017
• Last Verified: May 1, 2016

• Keywords provided by Poitiers University Hospital: VAP; Critical care; Pharmacokinetics; Gentamicin
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Gentamicins

Study Results

No Results Posted as of Mar 24, 2017