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Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia

2014-08-27 03:15:24 | BioPortfolio

Summary

A double-blind, three-arm study, to evaluate the safety and efficacy of two dosing regimens of zabofloxacin (a fluoroquinolone antibiotic) in community acquired pneumonia.

Description

The study is a Phase 2, global, prospective, multi-dose, double-blind, double-dummy, active-control, randomized, parallel-group, multicenter study of oral zabofloxacin HCl (400mg) versus oral levofloxacin (500mg) in the treatment of adults with community-acquired pneumonia of moderate severity.

Study Design

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

Conditions

Community Acquired Pneumonia

Intervention

Zabofloxacin, Levofloxacin 500mg, Zabofloxacin 400mg

Location

Ft. Myers
Florida
United States
33916

Status

Recruiting

Source

Pacific Beach BioSciences, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:24-0400

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Phase I clinical study to compare the pharmacokinetic profiles and bactericidal activity of Zabofloxacin 183mg, 367mg and Levofloxacin 250mg after oral administration in healthy volunteer

Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients

A clinical protocol was developed for the management of adult outpatients with community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients are assigned to o...

Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia

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Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

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PubMed Articles [2985 Associated PubMed Articles listed on BioPortfolio]

Serum 25-hydroxyvitamin D Levels in Hospitalized Adults with Community-Acquired Pneumonia.

Community-acquired pneumonia (CAP) is the infectious disease with the highest number of deaths worldwide. Several studies have shown an association between vitamin D deficiency and increases susceptib...

Guideline for Antibiotic Use in Adults with Community-acquired Pneumonia.

Community-acquired pneumonia is common and important infectious disease in adults. This work represents an update to 2009 treatment guideline for community-acquired pneumonia in Korea. The present cli...

Long-Term Cognitive Impairment after Hospitalization for Community-Acquired Pneumonia: a Prospective Cohort Study.

Recent studies suggest older patients hospitalized for community-acquired pneumonia are at risk for new-onset cognitive impairment. The characteristics of long-term cognitive impairment after pneumoni...

Chlamydia caviae Causing Community-Acquired Pneumonia: An Emerging Zoonosis.

We describe a case of community-acquired pneumonia due to Chlamydia caviae in a patient with no direct animal exposure, raising questions about the zoonotic reservoirs and potential transmission route...

Predicting 1-year mortality after hospitalization for community-acquired pneumonia.

Community-acquired pneumonia (CAP) is a major public health problem with high short- and long-term mortality. The main aim of this study was to develop and validate a specific prognostic index for one...

Medical and Biotech [MESH] Definitions

Any infection acquired in the community, that is, contrasted with those acquired in a health care facility (CROSS INFECTION). An infection would be classified as community-acquired if the patient had not recently been in a health care facility or been in contact with someone who had been recently in a health care facility.

The L-isomer of Ofloxacin.

The collective designation of three organizations with common membership: the European Economic Community (Common Market), the European Coal and Steel Community, and the European Atomic Energy Community (Euratom). It was known as the European Community until 1994. It is primarily an economic union with the principal objectives of free movement of goods, capital, and labor. Professional services, social, medical and paramedical, are subsumed under labor. The constituent countries are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, and the United Kingdom. (The World Almanac and Book of Facts 1997, p842)

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

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

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