Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

This study has been completed.

Study NCT00195351 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on September 12, 2005. Last Updated on April 23, 2010 History of Changes

Results First Received: February 27, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis
Interventions:	Drug: tigecycline Drug: ceftriaxone sodium + metronidazole

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 worldwide from September 2005 to February 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to two days.

Reporting Groups

	Description
Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Participant Flow: Overall Study

	Tigecycline	Ceftriaxone Sodium + Metronidazole
STARTED	236	231
COMPLETED	215	215
NOT COMPLETED	21	16
Lost to Follow-up	9	9
Withdrawal by Subject	6	3
Protocol Deviation	3	2
Death	3	1
Lack of Efficacy	0	1

Baseline Characteristics

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Reporting Groups

	Description
Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Baseline Measures

	Tigecycline	Ceftriaxone Sodium + Metronidazole	Total
Number of Participants [units: participants]	236	231	467
Age [units: years] Mean ± Standard Deviation	48.17 ± 18.05	48.79 ± 17.46	48.48 ± 17.74
Gender [units: participants]
Female	93	72	165
Male	143	159	302
Region of Enrollment [units: participants]
United States	163	169	332
Mexico	1	0	1
Canada	39	25	64
Argentina	4	2	6
Brazil	23	23	46
Chile	6	12	18

Outcome Measures

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1. Primary:

Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]

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2. Secondary:

Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]

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3. Secondary:

Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]

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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 by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81.

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00195351 History of Changes
Other Study ID Numbers:	3074A1-400
Study First Received:	September 12, 2005
Results First Received:	February 27, 2009
Last Updated:	April 23, 2010
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Committee of Ethics in Research; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Mexico: National Council of Science and Technology; United States: Institutional Review Board