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

Novexel

Status and phase: Completed; Phase 2

Conditions: Community Acquired Pneumonia

Treatments: Drug: NXL103; Drug: comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00653172

NXL103/2001

Details and patient eligibility

About

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

Enrollment: 302 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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302 participants in 3 patient groups

1

Experimental group

Description:

NXL103

Treatment:

Drug: NXL103

Drug: NXL103

3

Active Comparator group

Treatment:

Drug: comparator

2

Experimental group

Description:

NXL103

Treatment:

Drug: NXL103

Drug: NXL103