Phase 3 N=725 Randomized Quadruple-blind Treatment

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

Pneumonia, Bacterial

Bottom Line

View on ClinicalTrials.gov: NCT01799993 ↗

Enrolled (actual)

725

Serious AEs

27.8%

Results posted

Jun 2018

Primary outcome: Primary: Number of Participants Surviving Through LFU Visit — 191; 196; 64; 57 Participants — p=0.4263

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Amikacin Inhalation Solution (BAY41-6551) (Drug); Aerosolized Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Apr 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Surviving Through LFU Visit	191; 196; 64; 57	0.4263
SECONDARY Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit	43; 36; 21; 21	0.6421
SECONDARY Number of Participants With Early Clinical Response	149; 145; 106; 108	0.7984
SECONDARY Number of Days on Mechanical Ventilation Through LFU Visit	20.6; 20.2	0.7144
SECONDARY Number of Days in the ICU Through LFU Visit	21.3; 21.9	0.4278

Summary

To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (PDDS) Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative Pneumonia. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).

Eligibility Criteria

Inclusion Criteria

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) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
Impaired oxygenation
Clinical Pulmonary Infection Score (CPIS) of at least 6
Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms

Exclusion Criteria

History of hypersensitivity to amikacin or other aminoglycosides
Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
Known or suspected bacteremia secondary to Staphylococcus aureus
A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
Patients with a serum creatinine > 2 mg/dL (177 µmol/L) [Exception: Patients with a serum creatinine > 2 mg/dL (177 µmol/L) and being treated with continuous renal replacement therapy (Continuous Veno-Venous Hemodialysis and CVVHemoDiafiltration) or daily hemodialysis will receive the aerosol study drug treatment]
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 hrs, or any concomitant condition not related to ventilator-associated pneumonia that, in the opinion of the investigator, precludes completion of study evaluations and the course of therapy
Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)

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Data sourced from ClinicalTrials.gov (NCT01799993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.