Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia - Full Text View

Sponsored by:	Novexel Inc
Information provided by:	Novexel Inc
ClinicalTrials.gov Identifier:	NCT00653172

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental NXL103	Drug: NXL103 500mg orally twice daily
3: Active Comparator	Drug: comparator comparator twice daily
2: Experimental 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:	Novexel SA ( Dr. Carole A. Sable Chief Medical Officer )
Study ID Numbers:	NXL103/2001
Study First Received:	April 1, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00653172 History of Changes
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

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

Additional relevant MeSH terms:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on September 10, 2009