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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01799993
Registration number
NCT01799993
Ethics application status
Date submitted
25/02/2013
Date registered
27/02/2013
Date last updated
23/07/2018
Titles & IDs
Public title
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
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Scientific title
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
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Secondary ID [1]
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2013-001048-73
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Secondary ID [2]
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13084
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Universal Trial Number (UTN)
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Trial acronym
INHALE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pneumonia, Bacterial
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amikacin Inhalation Solution (BAY41-6551)
Treatment: Drugs - Aerosolized Placebo
Experimental: Amikacin inhale (BAY41-6551) - 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.
Placebo Comparator: Placebo - Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
Treatment: Drugs: Amikacin Inhalation Solution (BAY41-6551)
400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Treatment: Drugs: Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Surviving Through LFU Visit
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Assessment method [1]
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The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.
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Timepoint [1]
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Up to 28-32 days after start of study treatment
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Secondary outcome [1]
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Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit
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Assessment method [1]
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Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.
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Timepoint [1]
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Up to 28-32 days after start of study treatment
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Secondary outcome [2]
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Number of Participants With Early Clinical Response
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Assessment method [2]
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Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.
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Timepoint [2]
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Up to 10 days after start of study treatment
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Secondary outcome [3]
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Number of Days on Mechanical Ventilation Through LFU Visit
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Assessment method [3]
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Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.
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Timepoint [3]
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Up to 28-32 days after start of study treatment
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Secondary outcome [4]
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Number of Days in the ICU Through LFU Visit
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Assessment method [4]
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Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.
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Timepoint [4]
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Up to 28-32 days after start of study treatment
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/04/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/04/2017
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Sample size
Target
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Accrual to date
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Final
725
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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- Blacktown
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Recruitment hospital [2]
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- Clayton
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Recruitment hospital [3]
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- Wollongong
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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2500 - Wollongong
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Connecticut
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Delaware
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Florida
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Zlin
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Ankara
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Turkey
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Trabzon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Nektar Therapeutics
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01799993
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Address
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01799993
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