Overview

Phase II Study of Oral Nafithromycin in CABP

Status:
Completed

Trial end date:
2017-07-08

Target enrollment:
0

Participant gender:
All

Summary

Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wockhardt

Collaborator:

ACM

Treatments:

Fluoroquinolones
Moxifloxacin
Nafithromycin
Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

Meet the clinical criteria for CABP based on following:

1. Clinical symptoms (new or worsening)

2. Vital sign abnormalities

3. Laboratory abnormalities

4. Radiographic evidence of CABP

5. PORT score

Exclusion Criteria:

1. Subjects with any of the following confirmed or suspected types of pneumonia:

1. Aspiration pneumonia

2. Hospital-acquired bacterial pneumonia (HABP)

3. Healthcare-associated bacterial pneumonia (HCAP)

4. Ventilator-associated bacterial pneumonia (VABP)

5. Pneumonia that may be caused by pathogen(s) resistant to either study drug

2. Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial
treatment for treatment of the current CABP

3. Suspected or confirmed non-infectious causes of pulmonary infiltrates

4. Subjects requiring concomitant adjunctive or additional potentially-effective systemic
antibacterial treatment for management of CABP