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Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Tigecycline Vs Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia

NCT00079885•Wyeth is now a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

Summary

To compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with CAP requiring hospitalization. The co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the TOC visit. The primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. If tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects ≥ 18 years of ag.
•Subjects hospitalized with CAP for whom IV antibiotic treatment is indicated
•The presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°C/100.4°F, axillary temperature \>38.1°C/100.6°F, tympanic temperature \>38.5°C/ 101.2°F, or a rectal/core temperature \>39°C/102.2°F OR hypothermia (within 24 hours prior to randomization), core temperature \<35°C/95°

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 prior to the onset of symptoms
•Residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

Key Dates

Start Date

November 1, 2003

Primary Completion Date

July 1, 2005

Completion Date

July 1, 2005

Last Updated

February 8, 2013

Enrollment

430

ACTUAL participants

Conditions

Community Acquired PneumoniaBacterial PneumoniaCross Infection

Interventions

tigecycline

DRUG

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

NCT06804096

Pneumonia, Community-AcquiredBacterial Pneumonia

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RECRUITINGPHASE4

Optimising TREATment for Severe Gram-Negative Bacterial Infections

NCT07004049

Bloodstream InfectionVentilator Associated Bacterial Pneumonia+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP)

Optimising TREATment for Severe Gram-Negative Bacterial Infections

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

Derivation and Validation of the Risk Evaluation Score for Pneumonia Involving Resistant Entities (RESPIRE)

Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -

A Validation Study on a Prognostic Prediction Model for Respiratory Tract Infections