Completed

INHALE 1A 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

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What is being tested

Amikacin Inhalation Solution (BAY41-6551)

+ Aerosolized Placebo

Drug
Who is being recruted

Bacterial Infections and Mycoses+5

+ Bacterial Infections

+ Infections

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorBayer
Last updated: July 23, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 13, 2013

Actual date on which the first participant was enrolled.

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).

NCT01799993NCT00805168
Principal SponsorBayer
Last updated: July 23, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

725 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfectionsLung DiseasesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsPneumonia, Bacterial

Criteria

7 inclusion criteria required to participate
Clinical Pulmonary Infection Score (CPIS) of at least 6
Diagnosis of pneumonia defined as presence of a new or progressive infiltrate(s) on chest radiograph
Impaired oxygenation
Intubated and mechanically-ventilated
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10 exclusion criteria prevent from participating
A positive urine and/or serum beta-human Chorionic Gonadotropin pregnancy test
Has an Acute Physiology and Chronic Health Evaluation (APACHE) II score < 10
Has been on mechanical ventilation for > 28 days
Has received antibiotic therapy for Gram-negative pneumonia for greater than 48 hours at the time of randomization
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants received 400 mg (3.2 mL) aerosolized Amikacin (BAY41-6551) solution every 12 hours via Pulmonary Drug Delivery System (PDDS) Clinical from Day 1 to Day 10.

Group II

Placebo
Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 65 locations

Birmingham, United StatesOpen in Google Maps

Mobile, United States

Phoenix, United States

Danbury, United States
Completed65 Study Centers