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

Novexel Inc302 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

302

Conditions

Community Acquired Pneumonia

Interventions

NXL103DRUG

600mg orally twice daily

comparatorDRUG

comparator twice daily

NXL103DRUG

500mg orally twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (60)

Outcomes

Primary Outcomes

Evaluate Clinical outcome

Time frame: early follow up visit (day 14 to 21)

Secondary Outcomes

Evaluate bacteriological outcome

Time frame: early follow up visit (day 14 to 21)

Evaluate safety

Time frame: first dose, throughout treatment, and to follow up visit

Data from ClinicalTrials.gov

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