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Ceftobiprole in the Treatment of Hospital-Acquired Pulmonary Infections

2014-08-27 03:49:17 | BioPortfolio

Summary

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Description

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole medocaril is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole medocaril plus placebo versus a comparator to assess the effectiveness and safety of ceftobiprole medocaril in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole medocaril plus placebo or a comparator. The primary endpoint is the clinical cure rate of ceftobiprole medocaril at the test-of-cure visit. The patients will receive either ceftobiprole medocaril plus placebo or a comparator for 7 to 14 days (unless extended at discretion of medical monitor).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Pneumonia

Intervention

ceftobiprole medocaril

Status

Completed

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:49:17-0400

Clinical Trials [403 Associated Clinical Trials listed on BioPortfolio]

Ceftobiprole in the Treatment of Hospital-Acquired Pulmonary Infections

The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril versus a comparator in the treatment of patients with nosocomial pneumonia.

Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia

This is a study of the safety and efficacy of ceftobiprole in pediatric patients with hospital-acquired bacterial pneumonia (HAP) or community-acquired bacterial pneumonia (CAP) requiring ...

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

The purpose of this study is to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia...

Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device

Ceftobiprole is a very active new cephalosporin on staphylococci resistant to methicillin (SEMR: Staphylococcus epidermidis Resistant to Meticillin, SAMR: Staphylococcus aureus Resistant t...

Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.

PubMed Articles [509 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics and Target Attainment of Ceftobiprole in Asian and Non-Asian Subjects.

Ceftobiprole is a broad-spectrum cephalosporin. The objective of this study was to test the hypothesis that the pharmacokinetics (PK) and exposure of ceftobiprole in Asian subjects are similar to thos...

Incidence and case fatality rates of community-acquired pneumonia and pneumococcal diseases among Korean adults: Catchment population-based analysis.

Pneumonia is a leading infectious cause of morbidity and mortality among adults. Pneumococcal pneumonia (PP) is the most common vaccine-preventable bacterial etiology of pneumonia. In this study, we e...

Corticosteroids for pneumonia.

Pneumonia is a common and potentially serious illness. Corticosteroids have been suggested for the treatment of different types of infection, however their role in the treatment of pneumonia remains u...

Variation in the Diagnosis of Aspiration Pneumonia and Association with Hospital Pneumonia Outcomes.

Rationale National efforts to compare hospital outcomes for patients with pneumonia may be biased by hospital differences in diagnosis and coding of aspiration pneumonia, a condition that has traditio...

Is Lung Ultrasound Useful for Diagnosing Pneumonia in Children?: A Meta-Analysis and Systematic Review.

Childhood mortality due to pneumonia is high. Chest radiography is the primary imaging modality used for the evaluation of pneumonia in children. Lung ultrasonography (LUS) is a newer, alternative dia...

Medical and Biotech [MESH] Definitions

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

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

Severe complication of pneumonia characterized by liquefaction of lung tissue.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

Pneumonia caused by infections with the genus CHLAMYDIA; and CHLAMYDOPHILA, usually with CHLAMYDOPHILA PNEUMONIAE.

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