Gram-negaive pneumonia
Conditions
Interventions
Product Name: Amikacin Inhale
Product Code: BAY41-6551
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Amikacin
Current Sponsor code: BAY41-6551
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main inclusion criteria are: • Males and non-pregnant, non-lactating females, 18 years of age or older • Intubated and mechanically-ventilated • Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph and presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions • CPIS of at least 6 • At least two risk factors for multi-drug resistant organisms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The main exclusion criteria are: • Known local or systemic hypersensitivity to amikacin, other aminoglycosides, or components of the amikacin sulfate solution for inhalation • Has received antibiotic therapy for Gram-negative pneumonia for greater than 24 hours at the time of randomization • Primary lung cancer or another malignancy metastatic to the lungs or other known endobronchial obstructions • Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency virus (HIV) infection with CD 4 count 2 mg/dL (177 µmol/L) • Neutropenia (Screening ANC 28 days • Is participating in or has participated in other investigational interventional studies within the last 28 days prior to study treatment • 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 • Positive serum ß-hCG pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the TOC visit in patients with microbiologically confirmed Gram negative pneumonia.;Secondary Objective: The secondary objectives are to evaluate the efficacy of BAY 41-6551 (versus placebo) as measured by: •The number of days on mechanical ventilation •The number of ICU days at Day 28 •The number of IV antibiotics per patient per day used at TOC and Day 28 •CPIS changes through TOC •The clinical relapse rates at Day 28 •The all cause mortality rate during therapy, at Day 15, and at Day 28 •The number of hospital days at Day 28 ;Primary end point(s): The primary efficacy variable will be the clinical response at the Test-of-Cure (TOC) visit in the modified Intent-to-Treat (ie, ITT population plus a pre-therapy culture positive for a respiratory tract pathogen) population. | — |
Countries
Belgium, Czech Republic, France, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Spain
Outcome results
None listed