Clinical trial NCT00081575: Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study Of The Efficacy And Safety Of Intravenous Tigecycline Vs Intravenous Levofloxacin To Treat Subjects Hospitalized With Community-Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community-Acquired Infections
Bacterial Pneumonia
Cross Infection
Keywords: Bacterial Pneumonia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-04-19
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit.
measure: Determine whether tigecycline is noninferior to levofloxacin.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.