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A Study to Determine the Correct Dose of Amikacin Which is Delivered Directly to the Lungs of Ventilated Patients as an Aerosol Via an Investigational Device Called the Pulmonary Delivery Device System (PDDS)

2014-08-27 03:18:20 | BioPortfolio

Summary

This study is part of a research program too see if amikacin delivered as an aerosol directly to the lungs in combination with IV antibiotic therapy can help intubated patients with gram-negative pneumonia get better faster than when given intravenous antibiotics alone. The primary purpose of this study is to determine the correct dose of amikacin which is delivered directly to the lungs as an aerosol via an investigational device called the Pulmonary Delivery Device System (PDDS).

Study Design

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

Conditions

Pneumonia

Intervention

Amikacin (BAY41-6551), Amikacin (BAY41-6551), Placebo

Location

Birmingham
Alabama
United States
35233

Status

Completed

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:20-0400

Clinical Trials [421 Associated Clinical Trials listed on BioPortfolio]

Inhaled Amikacin Solution (BAY41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

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 intuba...

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

To evaluate the efficacy and safety of adjunctive aerosolized BAY41-6551 (amikacin inhalation solution) versus aerosolized placebo in the treatment of intubated and mechanically ventilated...

Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amik...

Pharmacokinetics of Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the d...

Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics d...

PubMed Articles [1470 Associated PubMed Articles listed on BioPortfolio]

Pharmacodynamics of inhaled amikacin (BAY 41-6551) studied in an in vitro pharmacokinetic model of infection.

The pharmacodynamics of inhaled antimicrobials are poorly studied. Amikacin is being developed for inhalational therapy as BAY 41-6551.

A Prospective Trial of Nebulized Amikacin in the Treatment of Bronchiectasis Exacerbation.

Pseudomonas aeruginosa is the most common pathogenic bacteria in bronchiectasis (BE) patients. The availability and security of nebulized amikacin treatment are unknown.

Pharmacodynamic interactions of amikacin with selected β-lactams and fluoroquinolones against canine Escherichia coli isolates.

Knowledge of in vitro antimicrobial interactions can serve as a guide for clinical application of combination antimicrobial regimens. The aim of the present study was to determine the pharmacodynamic ...

Implication of Haemodiafiltration Flow Rate on Amikacin Pharmacokinetic Parameters in Critically Ill Patients.

To analyse the effect of haemodiafiltration (CVVHDF) flow rate on amikacin pharmacokinetics and blood concentrations.

Time required to achieve maximum concentration of amikacin in synovial fluid of the distal interphalangeal joint after intravenous regional limb perfusion in horses.

OBJECTIVE To determine the maximum concentration (Cmax) of amikacin and time to Cmax (Tmax) in the distal interphalangeal (DIP) joint in horses after IV regional limb perfusion (IVRLP) by use of the c...

Medical and Biotech [MESH] Definitions

A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

Pneumonia due to aspiration or inhalation of various oily or fatty substances.

Severe complication of pneumonia characterized by liquefaction of lung tissue.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

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