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A study to test the safety and effectiveness of Bay 41-6551 as additional therapy to standard of care antimicrobial treatment in patients who have Gram-Negative Pneumonia and are intubated and mechani...

Update Il y a 5 ans
Reference: EUCTR2013-001048-73

A study to test the safety and effectiveness of Bay 41-6551 as additional therapy to standard of care antimicrobial treatment in patients who have Gram-Negative Pneumonia and are intubated and mechanially ventilated

Woman and Man

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Extract

To demonstrate that as adjunctive therapy to IV antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the PDDS Clinical every 12 hours is safe and more effective than placebo (aerosolized normal saline) administered as an aerosol by the PDDS Clinical every 12 hours, in intubated and mechanically-ventilated patients with Gram-negative pneumonia.

Inclusion criteria

  • Gram-negative pneumonia

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