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

Novexel Inc60 sites in 8 countries302 target enrollmentOctober 2007

ConditionsCommunity Acquired Pneumonia

InterventionsNXL103 comparator

DrugsNXL103 comparator

Overview

Phase: Phase 2
Intervention: NXL103
Conditions: Community Acquired Pneumonia
Sponsor: Novexel Inc
Enrollment: 302
Locations: 60
Primary Endpoint: Evaluate Clinical outcome
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

November 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novexel Inc

Eligibility 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