The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for
the treatment of mild to moderate community-acquired pneumonia (CAP).
Inclusion Criteria:
- Ambulatory male or female, 18 years of age or older
- If female, non-lactating and at no risk or pregnancy (post-menopausal or must use
adequate birth control)
- Positive Chest X-ray consistent with diagnosis of bacterial pneumonia
- Must be a suitable candidate for oral antibiotic therapy and must be able to swallow
capsules intact
- Recent history of respiratory illness consistent with the clinical signs and symptoms
of bacterial CAP
- Must be able to produce sputum
Exclusion Criteria:
- Prior hospitalization within previous 4 weeks
- Residence at a chronic care facility
- Active tuberculosis (or other mycobacterial infection, empyema, lung abscess,
pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic)
involving the lung, bronchial obstruction, a history of post-obstructive pneumonia
(chronic obstructive pulmonary disease [COPD] is not exclusionary), known or
suspected Pneumocystis carinii pneumonia
- Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment
with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or
subjects who have received more than 24 hours of treatment with other antibiotics
within 7 days prior to study drug administration
- Any infection which requires the use of a concomitant antimicrobial agent
- History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone,
azalide or streptogramin antimicrobials
- Treatment with another investigational drug within the last 4 weeks
- Females who are pregnant or lactating
- Subjects with known significant renal or hepatic impairment or disease
- Subjects with a history of impaired renal function
- Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic,
gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality
(other than the disease being studied)
- Subjects who would require parenteral antimicrobial therapy for the treatment of
pneumonia
- Any underlying disease or condition that would interfere with the completion of the
study procedures and evaluations or absorption of the study drug
- Currently receiving or are likely to require any of the following medications during
the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last
dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)
- Currently receiving or are likely to require any of the following during the period
from Evaluation 1 and within 24 hours after the last dose of study drug:
theophylline or theophylline analogues (unless adequately monitored), carbamazepine,
dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone,
warfarin and digitalis glycoside. Other barbiturates may be used with careful
monitoring
- Subjects who are currently receiving or who are likely to require any of the
following medications during the period between Evaluation 1 and 4: other systemic
antibiotic therapy, rifampin or rifabutin
- Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects
with known human immunodeficiency virus (HIV) infections and history of acquired
immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count
<200.
- Subject with known or suspected central nervous system (CNS) disorder that
predisposes them to seizures/lower seizure threshold (e. g., severe cerebral
arteriosclerosis, epilepsy)
- Previous treatment with cethromycin
- Subjects with signs of septic shock (e. g., mental confusion, severe hypoxemia, severe
hypotension, any other condition requiring intensive care unit [ICU] admission)
