Clinical Trials Logo

Clinical Trial Summary

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.


Clinical Trial Description

The primary purpose of this study is to demonstrate the safety and efficacy of the amikacin fosfomycin inhalation system (AFIS). AFIS consists of amikacin solution and fosfomycin solution, delivered by aerosol to the lungs via the PARI Investigational eFlow Inline System (eFlow Inline System). All patients will receive a standardized course of intravenous (IV) antibiotics for a minimum of 7 days. Patients will be randomized to receive 10 days of treatment with either AFIS or placebo, in addition to the IV therapy. The primary efficacy endpoint is defined as the change from baseline in the Clinical Pulmonary Infection Score (CPIS) during the randomized course of study drug. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01969799
Study type Interventional
Source Cardeas Pharma
Contact
Status Completed
Phase Phase 2
Start date December 2013
Completion date April 2016

See also
  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Withdrawn NCT02218359 - Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization Phase 2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