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

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

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

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 ]

Show Outcome Measure 1

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