E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the TOC visit in patients with microbiologically confirmed Gram negative pneumonia. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the efficacy of BAY 41-6551 (versus placebo) as measured by: • The number of days on mechanical ventilation • The number of ICU days at Day 28 • The number of IV antibiotics per patient per day used at TOC and Day 28 • CPIS changes through TOC • The clinical relapse rates at Day 28 • The all cause mortality rate during therapy, at Day 15, and at Day 28 • The number of hospital days at Day 28
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The main inclusion criteria are: • 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
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E.4 | Principal exclusion criteria |
The main exclusion criteria are: • Known local or systemic hypersensitivity to amikacin, other aminoglycosides, or components of the amikacin sulfate solution for inhalation • 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) • Neutropenia (Screening ANC < 103 neutrophils/mm3), stem cell transplant • 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 • Presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and follow-up could be completed • Positive serum β-hCG pregnancy test
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E.5 End points |
E.5.1 | Primary end point(s) |
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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as clean database |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |