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


Tracking Information

Start Date  ICMJEMarch 2010
Estimated Primary Completion DateOctober 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 8, 2008)		The Primary efficacy variable will be the clinical response at the test -of-Cure (TOC) visit in the modified Intent -to-Treat (ie, ITT population plus a pre-therapy culture positive for a respiratory tract pathogen) population [ Time Frame: 17-19 days after start of treatment with study medication ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00805168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 8, 2008)
  • 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 IV antibiotics per patient per day used at the TOC and Day 28 visits [ Time Frame: 17-19 days and then 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, number of hospital days at the Day 28 visit, clinical relapse rates at the Day 28 visit [ Time Frame: 28-32 days after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Mortality during the treatment period, Day 15, and Day 28 visit [ Time Frame: Days 1-10 (treatment period), Day 15 and then Days 28-32 after start of treatment with study medication ] [ Designated as safety issue: No ]
  • Per pathogen microbiological response rates at the TOC visit per patient microbiological response rate at the 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 Emergence of new potential respiratory pathogens during the treatment period, 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEInhaled Amikacin Solution (BAY41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Official Title  ICMJEA 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
Brief Summary

To evaluate if inhaled Amikacin Solution will increase the ability and safety of this antibiotic to treat Pneumonia in addition to giving intravenous antibiotics in patients who are intubated and mechanically-ventilated

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPneumonia
Intervention  ICMJE
  • Drug: Amikacin (BAY41-6551)
    400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
  • Drug: Aerosolized Placebo
    Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
Study Arms / Comparison Groups
  • Arm 1: Experimental
    Intervention: Drug: Amikacin (BAY41-6551)
  • Arm 2: Placebo Comparator
    Intervention: Drug: Aerosolized Placebo

Recruitment Information

Estimated Enrollment  ICMJE650
Estimated Completion DateOctober 2011
Estimated Primary Completion DateOctober 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions
  • CPIS of at least 6
  • At least two risk factors for multi-drug resistant organisms

Exclusion Criteria:

  • Has received antibiotic therapy for Gram-negative pneumonia for greater than 24 hours at the time of randomization
  • Primary lung cancer or another malignancy metastatic to the lungs or other known endobronchial obstructions
  • Known or suspected active tuberculosis, cystic fibrosis, human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3, or invasive fungal infection of the lung
  • Has had a stroke within five days
  • Burns greater than 40% of total body surface area
  • Screening serum creatinine > 2 mg/dL (177 µmol/L)
  • Has been on mechanical ventilation for > 28 days
  • Positive serum ß-hCG pregnancy test
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')(+)1-888-84 22937
Location Countries  ICMJEBelgium,   Bulgaria,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Japan,   Netherlands,   Poland,   Romania,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00805168
Responsible PartyTherapeutic Area Head, Bayer Schering Pharma AG
Study ID Numbers  ICMJE13085, 2008-000906-35
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer