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

NCT00081575

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community-Acquired Infections, Bacterial Pneumonia, Cross Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Community-Acquired Infections, Bacterial Pneumonia, Cross InfectionStudy Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
NCT00081575
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Official Title  ICMJE 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
Brief Summary To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Community-Acquired Infections
  • Bacterial Pneumonia
  • Cross Infection
Intervention  ICMJE
  • Drug: Tigecycline
  • Drug: Levofloxacin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2013)
434
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Bulgaria,   Croatia,   Czech Republic,   Estonia,   Germany,   Hungary,   India,   Latvia,   Lithuania,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT00081575
Other Study ID Numbers  ICMJE 3074A1-313
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP