study comparing the safety and efficacy of cethromycin to clarithromycin for the treatment of community-acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to compare the efficacy and safety of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (cap).

lower respiratory tract infections remain one of the leading causes of death worldwide. increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. in this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

Eligibility criteria:
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)

Keywords: pneumonia respiratory infection infectious advanced life sciences lung pulmonary cethromycin clarithromycin biaxin