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

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

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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:

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

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2. Secondary:

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

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3. Secondary:

Microbiological Response (Eradication Rate at the Subject Level) [ 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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Time Frame	No text entered.
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Frequency Threshold

Threshold above which other adverse events are reported	3%

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.

Other Adverse Events

	Tigecycline	Ceftriaxone Sodium + Metronidazole
Total, other (not including serious) adverse events
# participants affected	195	189
Blood and lymphatic system disorders
Thrombocythemia * # participants affected / at risk	13/236 (5.51%)	15/231 (6.49%)
Anemia * # participants affected / at risk	16/236 (6.78%)	8/231 (3.46%)
Leukocytosis * # participants affected / at risk	19/236 (8.05%)	4/231 (1.73%)
Cardiac disorders
Hypertension * # participants affected / at risk	9/236 (3.81%)	11/231 (4.76%)
Gastrointestinal disorders
Nausea * # participants affected / at risk	91/236 (38.56%)	64/231 (27.71%)
Vomiting * # participants affected / at risk	55/236 (23.31%)	41/231 (17.75%)
Diarrhea * # participants affected / at risk	42/236 (17.80%)	40/231 (17.32%)
Constipation * # participants affected / at risk	14/236 (5.93%)	14/231 (6.06%)
Ileus * # participants affected / at risk	8/236 (3.39%)	16/231 (6.93%)
Abdominal distension * # participants affected / at risk	5/236 (2.12%)	11/231 (4.76%)
Dyspepsia * # participants affected / at risk	9/236 (3.81%)	4/231 (1.73%)
Oral moniliasis * # participants affected / at risk	8/236 (3.39%)	1/231 (0.43%)
General disorders
Abdominal pain * # participants affected / at risk	22/236 (9.32%)	16/231 (6.93%)
Abscess * # participants affected / at risk	23/236 (9.75%)	15/231 (6.49%)
Headache * # participants affected / at risk	14/236 (5.93%)	22/231 (9.52%)
Fever * # participants affected / at risk	17/236 (7.20%)	18/231 (7.79%)
Infection * # participants affected / at risk	17/236 (7.20%)	9/231 (3.90%)
Generalized edema * # participants affected / at risk	1/236 (0.42%)	7/231 (3.03%)
Taste perversion * # participants affected / at risk	2/236 (0.85%)	9/231 (3.90%)
Metabolism and nutrition disorders
Hypokalemia * # participants affected / at risk	16/236 (6.78%)	21/231 (9.09%)
Healing abdominal * # participants affected / at risk	9/236 (3.81%)	8/231 (3.46%)
Hyperglycemia * # participants affected / at risk	9/236 (3.81%)	8/231 (3.46%)
Peripheral edema * # participants affected / at risk	9/236 (3.81%)	7/231 (3.03%)
Hypoproteinemia * # participants affected / at risk	11/236 (4.66%)	4/231 (1.73%)
Amylase increased * # participants affected / at risk	8/236 (3.39%)	4/231 (1.73%)
Hypophophatemia * # participants affected / at risk	3/236 (1.27%)	9/231 (3.90%)
SGPT increased * # participants affected / at risk	7/236 (2.97%)	5/231 (2.16%)
Nervous system disorders
Insomina * # participants affected / at risk	23/236 (9.75%)	24/231 (10.39%)
Anxiety * # participants affected / at risk	7/236 (2.97%)	12/231 (5.19%)
Confusion * # participants affected / at risk	8/236 (3.39%)	2/231 (0.87%)
Respiratory, thoracic and mediastinal disorders
Pharyngitis * # participants affected / at risk	9/236 (3.81%)	8/231 (3.46%)
Respiratory failure * # participants affected / at risk	6/236 (2.54%)	10/231 (4.33%)
Pulmonary physical findings * # participants affected / at risk	7/236 (2.97%)	6/231 (2.60%)
Dyspnea * # participants affected / at risk	5/236 (2.12%)	7/231 (3.03%)
Pleural effusion * # participants affected / at risk	4/236 (1.69%)	7/231 (3.03%)
Atelectasis * # participants affected / at risk	0/236 (0.00%)	7/231 (3.03%)
Skin and subcutaneous tissue disorders
Pruritus * # participants affected / at risk	13/236 (5.51%)	12/231 (5.19%)
Rash * # participants affected / at risk	4/236 (1.69%)	7/231 (3.03%)
Surgical and medical procedures
Local reaction to procedure * # participants affected / at risk	18/236 (7.63%)	14/231 (6.06%)
Vascular disorders
Deep vein thrombosis * # participants affected / at risk	8/236 (3.39%)	1/231 (0.43%)

*	Indicates events were collected by non-systematic assessment.

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 ( 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