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NCT00805168
Inhaled Amikacin Solution (BAY41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Tracking Information
Start Date ICMJE | March 2010 |
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Estimated Primary Completion Date | October 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 ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00805168 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 8, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Inhaled Amikacin Solution (BAY41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia |
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Official Title ICMJE | 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 |
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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Pneumonia |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 650 | ||||||||
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Estimated Completion Date | October 2011 | ||||||||
Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Japan, Netherlands, Poland, Romania, Russian Federation, Spain, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00805168 | ||||
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Responsible Party | Therapeutic Area Head, Bayer Schering Pharma AG | ||||
Study ID Numbers ICMJE | 13085, 2008-000906-35 | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer |
Source: http://clinicaltrials.gov/