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Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Novexel Inc
ClinicalTrials.gov Identifier:
NCT00653172
First received: April 1, 2008
Last updated: January 8, 2009
Last verified: January 2009

April 1, 2008
January 8, 2009
October 2007
June 2008   (final data collection date for primary outcome measure)
Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653172 on ClinicalTrials.gov Archive Site
  • Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]
  • Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia
A Double-Blind, Multicenter, Randomized, Double Dummy, Three-Arm Parallel-Group Comparative Study of the Efficacy, Safety and Tolerance of Oral NXL 103 Versus Oral Comparator in the Treatment of Community-Acquired Pneumonia in Adults

The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Community Acquired Pneumonia
  • Drug: NXL103
    600mg orally twice daily
  • Drug: comparator
    comparator twice daily
  • Drug: NXL103
    500mg orally twice daily
  • Experimental: 1
    NXL103
    Intervention: Drug: NXL103
  • Active Comparator: 3
    Intervention: Drug: comparator
  • Experimental: 2
    NXL103
    Intervention: Drug: NXL103
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
November 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Community acquired pneumonia

Exclusion Criteria:

  • severe CAP
  • respiratory infections attributed to sources other than community acquired bacterial infection
  • concomitant pulmonary disease
  • history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Croatia,   Estonia,   Germany,   Peru,   Poland,   Romania,   South Africa,   Ukraine
 
NCT00653172
NXL103/2001
No
Dr. Carole A. Sable Chief Medical Officer, Novexel SA
Novexel Inc
Not Provided
Not Provided
Novexel Inc
January 2009

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