Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

Bayer

Status and phase

Completed

Phase 2

Conditions

Pneumonia

Treatments

Drug: Amikacin inhalation solution (BAY41-6551)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01021436

06-IN-AK004

2006-005079-17 (EudraCT Number)

Details and patient eligibility

About

This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.

Exclusion criteria

Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine > 2mg/dl and chronic liver disease
Had primary lung cancer or another malignancy metastatic to the lungs
Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
Had a body mass index of ≥30 kg/m2
Had burns >40% of total body surface area
Had known local or systemic hypersensitivity to amikacin or aminoglycosides
Had a diagnosis of end-stage renal failure or were currently on dialysis treatment
Had a serum albumin level <2 g/dL at Screening
Used amikacin by any route within 7 days before the start of study treatment
Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed
Had known respiratory colonization with amikacin-resistant gram-negative rods