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

NCT00079885 | Completed Phase 3

• 1 other identifier: 3074A1-308
• Study Type: interventional
• Target: 430
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Community Acquired Pneumonia; Bacterial Pneumonia; Cross Infection

Keywords

Bacterial Pneumonia

Interventions

tigecycline DRUG

Eligibility Criteria

• Age: 18 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 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°

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 prior to 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 (2)

• Bergallo C, Jasovich A, Teglia O, Oliva ME, Lentnek A, de Wouters L, Zlocowski JC, Dukart G, Cooper A, Mallick R; 308 Study Group. Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. Diagn Microbiol Infect Dis. 2009 Jan;63(1):52-61. doi: 10.1016/j.diagmicrobio.2008.09.001. Epub 2008 Nov 5.

  PMID: 18990531 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 Pneumonia; Pneumonia, Bacterial; Cross Infection

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Lung 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

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: March 18, 2004
• First Posted: March 19, 2004
• Study Start: November 1, 2003
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: February 8, 2013

Record last verified: 2013-02