Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (INHALE 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Bayer
Sponsor:
Collaborators:
Nektar Therapeutics
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00805168
First received: December 8, 2008
Last updated: May 4, 2015
Last verified: May 2015
  Purpose

To evaluate the efficacy and safety of adjunctive aerosolized BAY 41-6551 (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


Condition Intervention Phase
Pneumonia, Bacterial
Drug: Amikacin Inhalation Solution (BAY41-6551)
Drug: Aerosolized Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Proportion of cured patients in the BAY41-6551 group divided by the proportion of cured patients in the placebo group [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days on mechanical ventilation through the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of intensive care unit (ICU) days at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of days in the hospital [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Relapse rates [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per patient microbiological response rates at the Test Of Cure (TOC) visit [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Microbiological recurrence rates at the TOC and Day 28 Visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Emergence of new potential respiratory pathogens during the treatment period. [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Emergence of resistance among baseline pathogens in those patients with persistent infection or colonization [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Number of patients who have received at least one dose of study drug and reported an adverse event [ Time Frame: After patient has signed Informed Consent until they have ended participation on the Study ] [ Designated as safety issue: Yes ]
  • Mortality during the treatment period, Day 15, and Day 28 visit [ Time Frame: 17-19 days and then 28-32 days after start of treatment with study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 650
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: 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)
Placebo Comparator: Arm 2 Drug: Aerosolized Placebo
Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805168

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 220 Study Locations
Sponsors and Collaborators
Bayer
Nektar Therapeutics
Novartis Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00805168     History of Changes
Other Study ID Numbers: 13085, 2008-000906-35
Study First Received: December 8, 2008
Last Updated: May 4, 2015
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
France: Ministry of Health
Spain: Ministry of Health
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Netherlands: Medical Ethics Review Committee (METC)
Norway: Norwegian Medicines Agency (Statens legemiddelverk, NOMA)Russia: Ethics Committee
Ukraine: Ministry of Health
China: Ministry of Health
Greece: Ethics Committee
Israel: Ministry of Health
Japan: Institutional Review Board
Portugal: The National Institute of Pharmacy and Medicines (Infarmed)

Keywords provided by Bayer:
Gram-negative Pneumonia
Pneumonia
Intubation
Mechanical ventilation
Amikacin

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amikacin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2015