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

This study has been completed.
Sponsor:
Information provided by:
Advanced Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT00336544
First received: June 9, 2006
Last updated: January 29, 2010
Last verified: January 2010

June 9, 2006
January 29, 2010
June 2006
May 2007   (final data collection date for primary outcome measure)
  • Clinical Cures in the Intent to Treat Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study ] [ Designated as safety issue: No ]
  • Clinical Cures in the Per Protocol Clinically Evaluable Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study ] [ Designated as safety issue: No ]
Clinical Cure Rate
Complete list of historical versions of study NCT00336544 on ClinicalTrials.gov Archive Site
  • Bacteriologic Cures in the Intent to Treat Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study ] [ Designated as safety issue: No ]
  • Bacteriologic Cures in the Per Protocol Clinically Evaluable Population [ Time Frame: Test of Cure Visit, defined as 14-22 days after the first dose of study ] [ Designated as safety issue: No ]
Bacteriologic Cure Rate
Not Provided
Not Provided
 
Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia
A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pneumonia
  • Drug: Cethromycin
    Cethromycin 300 mg once per day (QD) for 7 days, administered orally
    Other Names:
    • Restanza
    • ABT-773
  • Drug: Clarithromycin
    Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
    Other Names:
    • Biaxin
    • Klacid
    • Klaracid
  • Experimental: Cethromycin
    Intervention: Drug: Cethromycin
  • Active Comparator: Clarithromycin
    Intervention: Drug: Clarithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
522
May 2007
May 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00336544
CL06-001
No
David Eiznhamer, PhD, Executive Vice President, Clinical Development, Advanced Life Sciences
Advanced Life Sciences, Inc.
Not Provided
Study Director: David A. Eiznhamer, PhD. Advanced Life Sciences
Advanced Life Sciences, Inc.
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP