Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia



Status:Completed
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:11/8/2014
Start Date:December 2012
End Date:July 2014
Contact:Kay Clark, RN
Email:kclark@cempra.com

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

This study will evaluate the safety and efficacy of an experimental antibiotic,
solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary
parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or
dyspnea. The widespread emergence of antibiotic resistant pathogens, including the
macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective
antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation
macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key
typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed
comparable efficacy to levofloxacin in adults with CABP.

Inclusion Criteria:

- Male and female patients ≥ 18 years of age

- An acute onset of at least 3 of the following signs and symptoms (new or worsening):

1. Cough

2. Production of purulent sputum

3. Shortness of breath (dyspnea)

4. Chest pain due to pneumonia

- At least 1 of the following:

1. Fever

2. Hypothermia

3. Presence of pulmonary rales and/or evidence of pulmonary consolidation

- PORT Risk Class II, III, or IV

- Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with
acute bacterial pneumonia on a pulmonary imaging study

- Not received any systemic antibiotics during the prior 7 days

Exclusion Criteria:

- Ventilator-associated pneumonia

- Known anatomical or pathological bronchial obstruction or a history of bronchiectasis
or documented severe chronic obstructive pulmonary disease

- Hospitalization within 90 days or residence in a long-term care facility within 30
days prior to the onset of symptoms

- Presence of known:

1. Viral or fungal pneumonia

2. Pneumocystis jiroveci pneumonia

3. Aspiration pneumonia

4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism,
hypersensitivity pneumonia, congestive heart failure)

5. Primary or metastatic lung cancer

6. Cystic fibrosis

7. Active or suspected tuberculosis

- Known HIV or myasthesia gravis
We found this trial at
26
sites
?
mi
from
St Cloud, FL
Click here to add this to my saved trials
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Debary, FL
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Downingtown, Pennsylvania 19335
?
mi
from
Downingtown, PA
Click here to add this to my saved trials
?
mi
from
Duluth, GA
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
?
mi
from
Modesto, CA
Click here to add this to my saved trials
New Bedford, Massachusetts 02740
?
mi
from
New Bedford, MA
Click here to add this to my saved trials
?
mi
from
Oxnard, CA
Click here to add this to my saved trials
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Splendora, TX
Click here to add this to my saved trials
Summerville, South Carolina 29485
?
mi
from
Summerville, SC
Click here to add this to my saved trials
?
mi
from
Sylmar, CA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials