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

NCT00081575 | Completed Phase 3

• 1 other identifier: 3074A1-313
• Study Type: interventional
• Target: 434
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Community-Acquired Infections; Bacterial Pneumonia; Cross Infection

Keywords

Bacterial Pneumonia

Outcome Measures

Primary Outcomes (2)

• Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.

• Determine whether tigecycline is noninferior to levofloxacin.

Interventions

Tigecycline DRUG

Levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Related Publications (4)

• Ramirez JA, Cooper AC, Wiemken T, Gardiner D, Babinchak T; 308 Study Group. Switch therapy in hospitalized patients with community-acquired pneumonia: tigecycline vs. levofloxacin. BMC Infect Dis. 2012 Jul 19;12:159. doi: 10.1186/1471-2334-12-159.

  PMID: 22812672 DERIVED

• Tanaseanu C, Milutinovic S, Calistru PI, Strausz J, Zolubas M, Chernyak V, Dartois N, Castaing N, Gandjini H, Cooper CA; 313 Study Group. Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia. BMC Pulm Med. 2009 Sep 9;9:44. doi: 10.1186/1471-2466-9-44.

  PMID: 19740418 DERIVED

• Dartois N, Castaing N, Gandjini H, Cooper A; Tigecycline 313 Study Group. Tigecycline versus levofloxacin for the treatment of community-acquired pneumonia: European experience. J Chemother. 2008 Oct;20 Suppl 1:28-35. doi: 10.1179/joc.2008.20.Supplement-1.28.

  PMID: 19036672 DERIVED

• Tanaseanu C, Bergallo C, Teglia O, Jasovich A, Oliva ME, Dukart G, Dartois N, Cooper CA, Gandjini H, Mallick R; 308 Study Group; 313 Study Group. Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jul;61(3):329-38. doi: 10.1016/j.diagmicrobio.2008.04.009. Epub 2008 May 27.

  PMID: 18508226 DERIVED

MeSH Terms

Conditions

Community-Acquired Infections; Pneumonia, Bacterial; Cross Infection

Interventions

Tigecycline; Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Monitor, MD

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2004
• First Posted: April 19, 2004
• Study Start: January 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: February 8, 2013

Record last verified: 2013-02