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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653172

Enrollment

302

Registered

2008-04-04

Start date

2007-10-31

Completion date

2008-11-30

Last updated

2009-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia

Keywords

CAP, community acquired pneumonia

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

Interventions

DRUGNXL103

600mg orally twice daily

DRUGcomparator

comparator twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate Clinical outcome	early follow up visit (day 14 to 21)

Secondary

Measure	Time frame
Evaluate bacteriological outcome	early follow up visit (day 14 to 21)
Evaluate safety	first dose, throughout treatment, and to follow up visit

Countries

Chile, Croatia, Estonia, Germany, Peru, Poland, Romania, South Africa, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026