Status:
COMPLETED
Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)
Lead Sponsor:
Advanced Life Sciences, Inc.
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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).
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT00336505
Start Date
December 1 2005
End Date
October 1 2007
Last Update
February 26 2010
Active Locations (3)
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1
CANADA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
2
SOUTH AFRICA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517
3
USA - Advanced Life Sciences
Woodridge, Illinois, United States, 60517