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 3

Completed

• Conditions: Gram-negative Pneumonia; 10024970; 10004018

• Registration Number: NL-OMON44738
• Lead Sponsor: Bayer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Patients of age 18 and older, who are hospitalized, have pneumonia suspected or confirmed to be caused by Gram-negative organisms, and who are intubated and mechanically-ventilated will be selected for this study. In all patients where the pathogen is suspected of being Gram-negative, it should be confirmed as soon as culture results are available. Patients with microbiologically-confirmed pneumonia are those who have a Gram-negative organism cultured from an appropriate respiratory tract specimen collected prior to enrollment. 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
Presence of Gram-negative organism(s) indicated by Gramstain, or culture of pre-therapy respiratory specimen, or suspected Gram-negative pathogen
Impaired oxygenation
Clinical Pulmonary Infection Score (CPIS) * 6
The presence of a MDR organism in a pre-therapy respiratory
specimen OR at least two risk factors for MDR organisms

Exclusion Criteria

The main exclusion criteria are:
* A history of hypersensitivity to amikacin, or other
aminoglycosides,
* Has received systemic Gram-negative antibiotic therapy for greater than 48 hours at the time of administration of first dose of study drug. There should be as minimal a time delay as possible between randomization and first dose of study drug but up to 48 hours will be acceptable.
Exception: Systemic antibiotic therapy for more than 48 hours for gram-negative infection prior to administration of first dose of study drug is permitted if the infection is caused by pathogens that are resistant to the antimicrobial agent(s) used, or the patient*s pneumonia is worsening.
* Has primary lung cancer (including patients with small cell lung carcinoma/non-small cell lung carcinoma and patients with unknown histology) or another malignancy metastatic to
the lungs or other known endobronchial obstructions.
Exception: Please note that patients with complete resection of non-small cell lung carcinoma are eligible for the study.
* 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, lung abscess, or empyema
* Known or suspected bacteremia secondary to Staphylococcus
aureus
* Known or suspected neuromuscular disorders such as myasthenia gravis or parkinsonism
* Has had a stroke within five days
* A positive urine and/or serum beta-human chorionic gonadotropin (*-hCG) pregnancy test
* Burns greater than 40% of total body surface area
* Patients with a serum creatinine * 2 mg/dL (177 *mol/L)
Exception: Patients with a serum creatinine * 2 mg/dL (177 *mol/L) and being treated with continuous renal replacement therapy (continuous veno-venous hemofiltration [CVVH] and continuous veno-venous hemofiltration with dialysis[CVVH-D]) or daily hemodialysis will receive the
aerosol study drug treatment (Section 8.4.6.1)
* Neutropenia (Screening absolute neutrophil count [ANC] * 103 neutrophils/mm3)
* 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
* The risk of rapidly fatal illness and death within 72 hours, or any concomitant conditions not related to VAP that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
* Stem cell transplantation
* Patients with documented Legionella infection (eg, Legionella pneumonia)
* Has an Acute Physiology and Chronic Health Evaluation II (APACHE II) score < 10
* Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)

Study & Design

• Study Type: Interventional
• Study Design: Not specified