Phase II Study of Oral Nafithromycin in CABP

Status:	Completed
Conditions:	Pneumonia
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	8/2/2018
Start Date:	September 2016
End Date:	July 2017

A Phase II, Randomized, Double-Blind, Multicenter, Comparative 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

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

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

We found this trial at

sites

HCI Metromedic Walkin Medical Center

1155 Purchase Street
Bedford, Massachusetts 02740

Phone: +1 (508) 997 2900

from

Bedford, MA