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Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (INHALE 1)

Primary Purpose

Pneumonia, Bacterial

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Amikacin Inhalation Solution (BAY41-6551)
Aerosolized Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Bacterial focused on measuring Gram-negative pneumonia, Intubation, Mechanical ventilation, Amikacin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amikacin inhale (BAY41-6551)

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of Participants Surviving Through LFU Visit
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.

Secondary Outcome Measures

Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit
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.
Number of Participants With Early Clinical Response
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.
Number of Days on Mechanical Ventilation Through LFU Visit
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.
Number of Days in the ICU Through LFU Visit
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.

Full Information

First Posted
February 25, 2013
Last Updated
July 19, 2018
Sponsor
Bayer
Collaborators
Nektar Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01799993
Brief Title
Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Acronym
INHALE 1
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 13, 2013 (Actual)
Primary Completion Date
April 7, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Nektar Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Bacterial
Keywords
Gram-negative pneumonia, Intubation, Mechanical ventilation, Amikacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
725 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amikacin inhale (BAY41-6551)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 3.2 mL aerosolized placebo solution every 12 hours via PDDS Clinical from Day 1 to Day 10.
Intervention Type
Drug
Intervention Name(s)
Amikacin Inhalation Solution (BAY41-6551)
Intervention Description
400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Intervention Type
Drug
Intervention Name(s)
Aerosolized Placebo
Intervention Description
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Primary Outcome Measure Information:
Title
Number of Participants Surviving Through LFU Visit
Description
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.
Time Frame
Up to 28-32 days after start of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit
Description
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.
Time Frame
Up to 28-32 days after start of study treatment
Title
Number of Participants With Early Clinical Response
Description
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.
Time Frame
Up to 10 days after start of study treatment
Title
Number of Days on Mechanical Ventilation Through LFU Visit
Description
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.
Time Frame
Up to 28-32 days after start of study treatment
Title
Number of Days in the ICU Through LFU Visit
Description
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.
Time Frame
Up to 28-32 days after start of study treatment
Other Pre-specified Outcome Measures:
Title
Number of Participants With Microbiological Response Per Pathogen at TOC Visit
Description
The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure [TOC] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.
Time Frame
Up to 17-19 days after start of study treatment
Title
Number of Participants With Microbiological Response at TOC Visit
Description
The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.
Time Frame
Up to 17-19 days after start of study treatment
Title
Number of Participants With Microbiological Recurrence at LFU Visit
Description
The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as "recurrence". Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.
Time Frame
Up to 28-32 days after start of study treatment
Title
Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period
Description
New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group.
Time Frame
Up to 10 days after start of study treatment
Title
Number of Participants With Emergence of Resistance Among Pathogens
Description
Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used.
Time Frame
Up to 28-32 days after start of study treatment
Title
Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event
Description
AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).
Time Frame
Up to 7 days after the end of study treatment
Title
Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event
Description
AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: AE resulting in following outcomes or deemed significant for any reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent; significant disability/incapacity; congenital anomaly/birth defect; medical important serious event judged by investigator. SAEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent SAEs (TESAEs).
Time Frame
Up to 7 days after the end of study treatment
Title
Number of Participants With Organ Failure
Description
The overall number of participants with any organ failure was summarized for each treatment group. Organ failure was defined by a specific organ type and by a collection of MedDRA version 20.0 preferred terms that were determined by the sponsor's clinical team. A participant with multiple AEs within a system organ class or preferred term is counted a single time for that system organ class (SOC) or preferred term.
Time Frame
Up to 7 days after the end of study treatment
Title
Number of Death Due to Any Reason Through Day 10 and Day 15
Description
Number of deaths due to any reason through Day 10 and Day 15 were summarized for each treatment group.
Time Frame
Up to 10 days and 15 days after start of study treatment, respectively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008-4956
Country
United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-5421
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-3508
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65803
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0769
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150 221
Country
Brazil
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060904
Country
Brazil
City
São José do Rio Preto
State/Province
Sao Paulo
Country
Brazil
City
Kingston
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Barranquilla
State/Province
Atlántico
Country
Colombia
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
City
Zlin
ZIP/Postal Code
762 75
Country
Czechia
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
México, D.F.
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
City
Aguascalientes
ZIP/Postal Code
20000
Country
Mexico
City
San Luis Potosí
ZIP/Postal Code
78240
Country
Mexico
City
Quezon City
ZIP/Postal Code
1105
Country
Philippines
City
Quezon City
ZIP/Postal Code
NCR 1100
Country
Philippines
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Taipei
Country
Taiwan
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
31866328
Citation
Niederman MS, Alder J, Bassetti M, Boateng F, Cao B, Corkery K, Dhand R, Kaye KS, Lawatscheck R, McLeroth P, Nicolau DP, Wang C, Wood GC, Wunderink RG, Chastre J. Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial. Lancet Infect Dis. 2020 Mar;20(3):330-340. doi: 10.1016/S1473-3099(19)30574-2. Epub 2019 Dec 19.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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