Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-03-31

Brief Summary

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To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.

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Detailed Description

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Conditions

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Community-Acquired Infections Bacterial Pneumonia Cross Infection

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tigecycline

Intervention Type DRUG

Levofloxacin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects ≥ 18 years of age and in Bulgaria only ≤ 70 years of age
* Subjects hospitalized with CAP with a severity that requires IV antibiotic treatment for at least 7 days
* The presence of fever (within 24 hours before randomization)

Exclusion Criteria

* Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days).
* Hospitalization within 14 days before the onset of symptoms.
* Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No