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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Bacterial

Intervention: Amikacin Inhalation Solution (BAY41-6551) (Drug); Aerosolized Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Summary

To evaluate the efficacy and safety of adjunctive aerosolized BAY41-6551 (amikacin inhalation solution) versus aerosolized placebo in the treatment of intubated and mechanically ventilated adult patients with Gram-negative pneumonia receiving standard of care intravenous antibiotics

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of cured patients in the BAY41-6551 group divided by the proportion of cured patients in the placebo group

Secondary outcome:

Number of days on mechanical ventilation through the Day 28 visit

Number of intensive care unit (ICU) days at the Day 28 visit

Number of hospital days at the Day 28 visit

Relapse rate

Per pathogen microbiological response rates at the Test-of-Cure (TOC) visit

Per patient microbiological response rates at the TOC visit

Microbiological recurrence rates at the TOC visit

Microbiological recurrence rates at the Day 28 Visit

Emergence of new potential respiratory pathogens during the treatment period

Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization

Number of patients who have received at least one dose of study drug and reported an adverse event

Mortality during the treatment period at TOC visit

Mortality during the treatment period at Late-follow-up visit

Clinical Pulmonary Infection Score (CPIS) changes through TOC

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 or at least two risk factors for multi-drug resistant 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 umol/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)

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Buenos Aires [Capital Federal] 1120, Argentina; Not yet recruiting

Córdoba 5000, Argentina; Not yet recruiting

Mendoza 5500, Argentina; Not yet recruiting

Wollongong 2500, Australia; Recruiting

Sao Paulo 04012-000, Brazil; Terminated

Bogotá, Colombia; Not yet recruiting

Hradec Kralove 500 05, Czech Republic; Not yet recruiting

Praha 10 100 34, Czech Republic; Recruiting

Praha 5 150 06, Czech Republic; Not yet recruiting

Usti nad Labem 401 13, Czech Republic; Terminated

Zlin 762 75, Czech Republic; Recruiting

Incheon 405-760, Korea, Republic of; Not yet recruiting

Seoul 138-736, Korea, Republic of; Recruiting

Seoul 136-705, Korea, Republic of; Recruiting

Seoul 137-701, Korea, Republic of; Recruiting

Seoul 120-752, Korea, Republic of; Not yet recruiting

Seoul 152-703, Korea, Republic of; Not yet recruiting

Aguascalientes 20000, Mexico; Not yet recruiting

México, D.F. 07760, Mexico; Not yet recruiting

San Luis Potosí 78240, Mexico; Recruiting

Lima 31, Peru; Not yet recruiting

Lima LIMA 11, Peru; Not yet recruiting

Lima LIMA 1, Peru; Not yet recruiting

Lima, Peru; Not yet recruiting

Manila, Philippines; Not yet recruiting

Quezon City 1105, Philippines; Not yet recruiting

Quezon City, Philippines; Not yet recruiting

Kaohsiung, Taiwan; Recruiting

Kaoshiung 81346, Taiwan; Not yet recruiting

Tainan 710, Taiwan; Recruiting

Taipei 11217, Taiwan; Recruiting

Taipei, Taiwan; Recruiting

Chiang Mai 50200, Thailand; Recruiting

Khon Kaen 40002, Thailand; Recruiting

Ankara 06100, Turkey; Recruiting

Istanbul 34098, Turkey; Not yet recruiting

Istanbul 34160, Turkey; Not yet recruiting

Istanbul 34160, Turkey; Terminated

Izmir 35100, Turkey; Not yet recruiting

Trabzon 61080, Turkey; Recruiting

Birmingham, Alabama 35233, United States; Recruiting

Mobile, Alabama 36617, United States; Not yet recruiting

Phoenix, Arizona 85008-4956, United States; Recruiting

Barranquilla, Atlántico, Colombia; Not yet recruiting

Merlo, Buenos Aires B1712FJN, Argentina; Terminated

San Diego, California 92103-8896, United States; Not yet recruiting

Stanford, California 94305, United States; Not yet recruiting

Chihuahua, Chih., Chihuahua 31000, Mexico; Not yet recruiting

Buenos Aires, Ciudad Auton. de Buenos Aires C1181ACH, Argentina; Not yet recruiting

Denver, Colorado 80204, United States; Not yet recruiting

Danbury, Connecticut 06810, United States; Recruiting

Farmington, Connecticut 06030, United States; Not yet recruiting

Hartford, Connecticut 06102, United States; Recruiting

Cordoba, Córdoba 5000, Argentina; Not yet recruiting

Newark, Delaware 19718-2200, United States; Recruiting

Bogotá, Distrito Capital de Bogotá, Colombia; Not yet recruiting

México D.F., Distrito Federal 14080, Mexico; Not yet recruiting

Hollywood, Florida 33021-5421, United States; Recruiting

Jacksonville, Florida 32209, United States; Terminated

Miami, Florida 33125, United States; Recruiting

Miami, Florida 33136, United States; Not yet recruiting

Sarasota, Florida 34232, United States; Not yet recruiting

Tampa, Florida 33606-3508, United States; Recruiting

Wonju-si, Gang''weondo 220-701, Korea, Republic of; Not yet recruiting

Atlanta, Georgia 30342, United States; Recruiting

Augusta, Georgia 30909, United States; Not yet recruiting

Chicago, Illinois 60611, United States; Not yet recruiting

Chicago, Illinois 60612, United States; Not yet recruiting

Peoria, Illinois 61606, United States; Terminated

Springfield, Illinois 62702, United States; Recruiting

Indianapolis, Indiana 46202, United States; Not yet recruiting

Muncie, Indiana 47303, United States; Recruiting

Iowa City, Iowa 52242, United States; Not yet recruiting

Guadalajara, Jalisco 44280, Mexico; Terminated

Guadalajara, Jalisco 44340, Mexico; Not yet recruiting

Hazard, Kentucky 41701, United States; Not yet recruiting

Portland, Maine 04102, United States; Terminated

Baltimore, Maryland 21201, United States; Not yet recruiting

Springfield, Massachusetts 01199, United States; Terminated

Ann Arbor, Michigan 48109-0330, United States; Not yet recruiting

Detroit, Michigan 48202, United States; Terminated

Grand Blanc, Michigan 48439, United States; Not yet recruiting

Kalamazoo, Michigan 49007, United States; Recruiting

Royal Oak, Michigan 48073, United States; Not yet recruiting

Belo Horizonte, Minas Gerais 30150 221, Brazil; Recruiting

Springfield, Missouri 65803, United States; Recruiting

St. Louis, Missouri 63110-1093, United States; Not yet recruiting

Butte, Montana 59701, United States; Recruiting

Toluca, México 50130, Mexico; Terminated

Las Vegas, Nevada 89109, United States; Recruiting

Englewood, New Jersey 07631, United States; Not yet recruiting

Blacktown, New South Wales 2148, Australia; Recruiting

Herston, New South Wales 4029, Australia; Terminated

Herston, New South Wales 4029, Australia; Not yet recruiting

Brooklyn, New York 11215, United States; Recruiting

Buffalo, New York 14215, United States; Not yet recruiting

Johnson City, New York 13790, United States; Not yet recruiting

Mineola, New York 11501, United States; Recruiting

New York, New York 10019, United States; Not yet recruiting

New York, New York 10065, United States; Recruiting

New York, New York 10029, United States; Not yet recruiting

Asheville, North Carolina 28801, United States; Recruiting

Greensboro, North Carolina 27401, United States; Recruiting

Monterrey, Nuevo Leon 64460, Mexico; Not yet recruiting

Cincinnati, Ohio 45267-0769, United States; Recruiting

Cleveland, Ohio 44109-1998, United States; Recruiting

Columbus, Ohio 43215, United States; Recruiting

Middletown, Ohio 45005, United States; Not yet recruiting

Youngstown, Ohio 44501, United States; Recruiting

Oklahoma City, Oklahoma 73117, United States; Not yet recruiting

Ottawa, Ontario K1H 8L6, Canada; Recruiting

Curitiba, Parana 80440-080, Brazil; Terminated

Montreal, Quebec H1T 2M4, Canada; Recruiting

Porto Alegre, Rio Grande do Sul 90035-074, Brazil; Terminated

Porto Alegre, Rio Grande do Sul 90610-000, Brazil; Not yet recruiting

Porto Alegre, Rio Grande do Sul 90450 130, Brazil; Terminated

Porto Alegre, Rio Grande do Sul 90110 270, Brazil; Terminated

Campinas, Sao Paulo 13060904, Brazil; Recruiting

São José do Rio Preto, Sao Paulo, Brazil; Recruiting

Hermosillo, Sonora 83000, Mexico; Not yet recruiting

Adelaide, South Australia 5011, Australia; Not yet recruiting

Charleston, South Carolina 29425, United States; Recruiting

Hobart, Tasmania 7000, Australia; Terminated

Knoxville, Tennessee 37920, United States; Not yet recruiting

Memphis, Tennessee 38163, United States; Not yet recruiting

Nashville, Tennessee 37212, United States; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

San Antonio, Texas 78229-3900, United States; Not yet recruiting

San Antonio, Texas 78229, United States; Not yet recruiting

Cali, Valle del Cauca, Colombia; Recruiting

Clayton, Victoria 3168, Australia; Recruiting

Footscray, Victoria 3011, Australia; Not yet recruiting

Parkville, Victoria 3050, Australia; Terminated

Richmond, Victoria 3122, Australia; Not yet recruiting

Charleston, West Virginia 25304, United States; Not yet recruiting

Additional Information

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Starting date: April 2013
Last updated: August 3, 2015

Page last updated: August 20, 2015

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