A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

Phase 1

• Conditions: Gram-negaive pneumonia

• Registration Number: EUCTR2008-000906-35-CZ
• Lead Sponsor: Bayer Schering Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-09-03
• Study Completion: 2017-04-07
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 712

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

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 < 200 cell/mm3, or invasive fungal infection of the lung
•Has had a stroke within five days
•Burns greater than 40% of total body surface area
•Screening serum creatinine > 2 mg/dL (177 µmol/L)
•Neutropenia (Screening ANC < 103 neutrophils/mm3), stem cell transplant
•Has been on mechanical ventilation for > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified