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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
History of Changes
Results First Received: September 3, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pneumonia
Interventions: Drug: Cethromycin
Drug: Clarithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited globally from July 2006 through May 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the clarithromycin treatment arm, one subject was enrolled and randomized to a blinded treatment but discontinued from study prior to administration of the first dose of drug. Thus, while official enrollment totaled 522 subjects, only 521 were randomized and dosed with blinded study drug.

Reporting Groups
  Description
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Participant Flow:   Overall Study
    Cethromycin     Clarithromycin  
STARTED     261 [1]   260 [1]
COMPLETED     242 [2]   238 [2]
NOT COMPLETED     19     22  
Lack of Efficacy                 8                 5  
Adverse Event                 4                 9  
Withdrawal by Subject                 4                 3  
Unknown                 3                 5  
[1] All subjects who were randomized and dosed.
[2] Number of subjects completing the test of cure (TOC) visit.



  Baseline Characteristics
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Reporting Groups
  Description
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally
Total Total of all reporting groups

Baseline Measures
    Cethromycin     Clarithromycin     Total  
Number of Participants  
[units: participants]
 		  261     260     521  
Age [1]
[units: years]
Mean ± Standard Deviation 		  47.7  ± 16.8     46.8  ± 17.6     47.3  ± 17.2  
Gender [1]
[units: participants]
 		     
Female     123     134     257  
Male     138     126     264  
[1] All subjects who were randomized and dosed.



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Primary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: David Eiznhamer, PhD, Executive Vice President, Clinical Development
Organization: Advanced Life Sciences
phone: 630-739-6744
e-mail: deiznhamer@advancedlifesciences.com


No publications provided


Responsible Party: David Eiznhamer, PhD, Executive Vice President, Clinical Development, Advanced Life Sciences
ClinicalTrials.gov Identifier: NCT00336544     History of Changes
Other Study ID Numbers: CL06-001
Study First Received: June 9, 2006
Results First Received: September 3, 2009
Last Updated: January 29, 2010
Health Authority: United States: Food and Drug Administration