Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia

Advanced Life Sciences

Status and phase

Completed

Phase 3

Conditions

Pneumonia

Treatments

Drug: Clarithromycin

Drug: Cethromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00336544

CL06-001

Details and patient eligibility

About

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).

Full description

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.

Enrollment

522 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)