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

This study has been completed.

Study NCT00336544 Information provided by Advanced Life Sciences, Inc.

First Received on June 9, 2006. Last Updated on January 29, 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

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 ]

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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 ]

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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 ]

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

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