Pneumonia, Bacterial Clinical Trial
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
To demonstrate that as adjunctive therapy to intravenous (IV) antibiotics, BAY 41-6551 400 mg (amikacin as free base) administered as an aerosol by the Pulmonary Drug Delivery System (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. The secondary endpoint objectives are to evaluate the superiority of aerosolized BAY 41-6551 versus aerosolized placebo in pneumonia-related mortality, the Early Clinical Response at Day 10, the days on ventilation, and the days in the intensive care unit (ICU).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03303976 -
Phase I to Test a New Pneumococcal Vaccine
|
Phase 1 | |
| Completed |
NCT02459158 -
A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia
|
Phase 1 | |
| Completed |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
| Active, not recruiting |
NCT03577964 -
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
|
||
| Completed |
NCT04540081 -
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
|
N/A | |
| Completed |
NCT00538694 -
Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia
|
Phase 3 | |
| Withdrawn |
NCT02218359 -
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization
|
Phase 2 | |
| Completed |
NCT01189487 -
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
|
Phase 3 | |
| Completed |
NCT00515034 -
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
|
Phase 2 | |
| Withdrawn |
NCT00245453 -
Outpatient Registry Trial of Respiratory Tract Infections in Adults
|
Phase 4 | |
| Completed |
NCT03239665 -
Vaccination Education Through Pharmacists and Senior Centers (VEPSC)
|
N/A | |
| Completed |
NCT03034642 -
Modulation of Steroid Immunosuppression by Alveolar Efferocytosis
|
N/A | |
| Completed |
NCT04047719 -
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
|
||
| Completed |
NCT02292498 -
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
|
N/A | |
| Completed |
NCT01763008 -
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
|
Phase 4 | |
| Recruiting |
NCT05976581 -
Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
|
N/A | |
| Completed |
NCT03551210 -
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
|
Phase 3 | |
| Completed |
NCT04158804 -
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
|
N/A | |
| Completed |
NCT00805168 -
Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
|
Phase 3 | |
| Completed |
NCT02778672 -
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
|
N/A |