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

This study has been completed.

Study NCT00195351 Information provided by Wyeth

First Received: September 12, 2005 Last Updated: April 16, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Single Group Assignment
Conditions:	Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis
Interventions:	Drug: tigecycline Drug: ceftriaxone sodium + metronidazole

Participant Flow

Hide Participant Flow

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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit. [ 10-21 days after the last dose of test article ]

Hide Outcome Measure 1

Measure Type	Primary
Measure Title	Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit.
Measure Description	The investigator evaluated the subject’s clinical response as Cure, Failure or Indeterminate.
Time Frame	10-21 days after the last dose of test article
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis population was the Clinically Evaluable Population.

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.

Measured Values

	Tigecycline	Ceftriaxone Sodium + Metronidazole
Number of Participants Analyzed [units: participants]	189	187
Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit. [units: of participants cured]	133	139

Statistical Analysis 1 for Clinical Response in the Clinically Evaluable Population at the Test-of-Cure Visit.

Groups ^[1]	All groups
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.009
Risk Difference (RD) ^[4]	-4.0
95% Confidence Interval	( -13.1 to 5.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

Clinical Response in the Microbiologically Evaluable Population [ 10-21 days after the last dose of test article ]

Show Outcome Measure 2

3. Secondary:

Microbiological Response (Eradication Rate at the Subject Level) [ 10-21 days after the last dose of test article ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
No text entered.

Results Point of Contact:

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

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-400
Study First Received:	September 12, 2005
Results First Received:	February 27, 2009
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00195351 History of Changes
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