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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00336505
Recruitment Status : Completed
First Posted : June 13, 2006
Results First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
Advanced Life Sciences, Inc.

Tracking Information
First Submitted Date  ICMJE June 9, 2006
First Posted Date  ICMJE June 13, 2006
Results First Submitted Date  ICMJE September 3, 2009
Results First Posted Date  ICMJE February 26, 2010
Last Update Posted Date February 26, 2010
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2010)
  • 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 drug. ]
  • 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 drug ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Clinical Cure Rate
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2010)
  • 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 drug. ]
  • 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 drug. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Bacteriologic Cure Rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)
Official Title  ICMJE A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin (BIAXIN® Filmtab®) 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pneumonia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Clarithromycin
    Intervention: Drug: Clarithromycin
  • Experimental: Cethromycin
    Intervention: Drug: Cethromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2010)
584
Original Enrollment  ICMJE
 (submitted: June 9, 2006)
500
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00336505
Other Study ID Numbers  ICMJE CL05-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Eiznhamer, PhD, Executive Vice President, Clinical Development, Advanced Life Sciences
Study Sponsor  ICMJE Advanced Life Sciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David A. Eiznhamer, PhD Advanced Life Sciences
PRS Account Advanced Life Sciences, Inc.
Verification Date January 2010

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