Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

This study has been completed.

Study NCT00366249 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on August 17, 2006. Last Updated on April 22, 2010 History of Changes

Results First Received: July 14, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Conditions:	Bacterial Infections Diabetic Foot Osteomyelitis
Interventions:	Drug: Tigecycline Drug: Ertapenem

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
Patients were recruited worldwide from January 2007 to February 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for up to 24 hours.

Reporting Groups

	Description
Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
Ertapenem	Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).

Participant Flow: Overall Study

	Tigecycline	Ertapenem
STARTED	553	508
COMPLETED	422	430
NOT COMPLETED	131	78
Adverse Event	53	28
Death	0	1
Physician Decision	5	2
Lost to Follow-up	2	0
Protocol Violation	1	2
Withdrawal by Subject	18	4
Lack of Efficacy	21	21
Most due to osteomylitis status	31	20

Baseline Characteristics

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Reporting Groups

	Description
Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
Ertapenem	Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).

Baseline Measures

	Tigecycline	Ertapenem	Total
Number of Participants [units: participants]	553	508	1061
Age [units: years] Mean ± Standard Deviation	59.36 ± 12.04	58.75 ± 11.70	59.07 ± 11.88
Gender [units: participants]
Female	199	165	364
Male	354	343	697

Outcome Measures

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1. Primary:

Number of Patients With Clinical Response of Cure Vs. Failure. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ]

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2. Primary:

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ]

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3. Secondary:

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose. [ Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose ]

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4. Secondary:

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose. [ Time Frame: Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose ]

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5. Secondary:

Number of Patients With Microbiologic Response of Eradication. [ Time Frame: Test of cure visit (TOC): Assessed at least 12 days post last dose ]

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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: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

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
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Results Point of Contact:

Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00366249 History of Changes
Other Study ID Numbers:	3074K5-319
Study First Received:	August 17, 2006
Results First Received:	July 14, 2009
Last Updated:	April 22, 2010
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Human Research Ethics Committee Brazil: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile China: Ministry of Health European Union: European Medicines Agency Hong Kong: Department of Health India: Ministry of Health Korea: Food and Drug Administration Mexico: Ethics Committee Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Singapore: Health Sciences Authority South Africa: Medicines Control Council Taiwan: Department of Health United States: Food and Drug Administration