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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653172
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : January 9, 2009
Sponsor:
Information provided by:
Novexel Inc

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: NXL103 Drug: comparator Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
NXL103
 Drug: NXL103
500mg orally twice daily
Active Comparator: 3 Drug: comparator
comparator twice daily
Experimental: 2
NXL103
 Drug: NXL103
600mg orally twice daily


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ]

Secondary Outcome Measures :
  1. Evaluate bacteriological outcome [ Time Frame: early follow up visit (day 14 to 21) ]
  2. Evaluate safety [ Time Frame: first dose, throughout treatment, and to follow up visit ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653172


Locations
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Sponsors and Collaborators
Novexel Inc
More Information
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Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172    
Other Study ID Numbers: NXL103/2001
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009
Keywords provided by Novexel Inc:
CAP
community acquired pneumonia
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Streptogramin A
Anti-Bacterial Agents
Anti-Infective Agents