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

This study has been completed.

Study NCT00230971 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on September 30, 2005. Last Updated on April 5, 2010 History of Changes

Results First Received: September 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-abdominal Infection Peritonitis
Interventions:	Drug: tigecycline Drug: ceftriaxone plus 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
Patients were recruited worldwide from November 2005 to July 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened according to the inclusion/exclusion criteria. Once informed consent was obtained, the patient was enrolled into the study and assigned a randomization number and a treatment regimen.

Reporting Groups

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

Participant Flow for 2 periods

Period 1: Randomization

	Tigecycline	Ceftriaxone
STARTED	235	238
COMPLETED	232	235
NOT COMPLETED	3	3
No study drug dosed	3	3

Period 2: Baseline Participants

	Tigecycline	Ceftriaxone
STARTED	232	235
COMPLETED	210	216
NOT COMPLETED	22	19
Lost to Follow-up	5	12
Death	6	5
Withdrawal by Subject	7	1
Adverse event	1	0
No bacteria observed	1	0
Failure to return	1	1
Reintervention	1	0

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	Tigecycline	Ceftriaxone	Total
Number of Participants [units: participants]	232	235	467
Age [units: years] Mean ± Standard Deviation	48.55 ± 18.37	46.81 ± 18.38	47.67 ± 18.37
Gender [units: participants]
Female	80	72	152
Male	152	163	315

Outcome Measures

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1. Primary:

Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]

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2. Secondary:

Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]

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3. Secondary:

Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit [ Time Frame: up to 6 weeks ]

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4. Secondary:

Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure [ Time Frame: up to 6 weeks ]

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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:	NCT00230971 History of Changes
Other Study ID Numbers:	3074A1-315
Study First Received:	September 30, 2005
Results First Received:	September 30, 2009
Last Updated:	April 5, 2010
Health Authority:	European Union: European Medicines Agency; Australia: Human Research Ethics Committee; Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; India: Institutional Review Board; Republic of the Philippines: Ethics Committee; Taiwan: Institutional Review Board; Denmark: Ethics Committee; Finland: National Advisory Board on Health Care Ethics; France: Institutional Ethical Committee; Germany: Ethics Commission; Greece: Ethics Committee; Italy: Ethics Committee; Saudi Arabia: Ethics Committee; South Africa: Human Research Ethics Committee; Spain: Ethics Committee; Switzerland: Ethikkommission; Turkey: Ministry of Health; United Kingdom: Research Ethics Committee