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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
History of Changes
  Purpose

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 Intervention Phase
Community Acquired Pneumonia
 Drug: NXL103
Drug: comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Further study details as provided by Novexel Inc:

Primary Outcome Measures:
  • Evaluate Clinical outcome [ Time Frame: early follow up visit (day 14 to 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 302
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653172

  Show 60 Study Locations
Sponsors and Collaborators
Novexel Inc
  More Information

No publications provided

Responsible Party: Dr. Carole A. Sable Chief Medical Officer, Novexel SA
ClinicalTrials.gov Identifier: NCT00653172     History of Changes
Other Study ID Numbers: NXL103/2001
Study First Received: April 1, 2008
Last Updated: January 8, 2009
Health Authority: Croatia: Ministry of Health and Social Care
Chile: Instituto de Salud Publica de Chile
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
South Africa: Medicines Control Council
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Novexel Inc:
CAP
community acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 19, 2013