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

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00230971

Purpose

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

Condition	Intervention	Phase
Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-abdominal Infection Peritonitis	Drug: tigecycline Drug: ceftriaxone plus metronidazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection

Resource links provided by NLM:

MedlinePlus related topics: Appendicitis Diverticulosis and Diverticulitis

Drug Information available for: Metronidazole hydrochloride Metronidazole phosphate Ceftriaxone Ceftriaxone Sodium Tigecycline Metronidazole

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Clinical response in the clinically evaluable population at the Test-of-Cure visit. [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]
To compare health care utilization between treatment groups [ Time Frame: 10-21 days after the last dose of test article. ] [ Designated as safety issue: No ]

Enrollment:	473
Study Start Date:	October 2005
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
B: Active Comparator	Drug: ceftriaxone plus metronidazole Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

Cancer
Medicines that suppress the immune system
Dialysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230971

Show 68 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Australia, China, Hong Kong, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Taiwan, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Denmark, Finland, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For South Africa, ZAFinfo@wyeth.com
Principal Investigator:	Trial Manager	For Italy, Greece, decresg@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com
Principal Investigator:	Trial Manager	For France, infomedfrance@wyeth.com
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com
Principal Investigator:	Trial Manager	For Turkey, Erisc@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-315
Study First Received:	September 30, 2005
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00230971 History of Changes
Health Authority:	European Union: European Medicines Agency

Keywords provided by Wyeth:

Intra-Abdominal Infections
Abscess

Additional relevant MeSH terms:

Gallbladder Diseases
Communicable Diseases
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Gastrointestinal Diseases
Tigecycline
Physiological Effects of Drugs
Infection
Diverticulitis
Anti-Bacterial Agents
Antiparasitic Agents
Pathologic Processes
Acalculous Cholecystitis
Therapeutic Uses

Appendicitis
Biliary Tract Diseases
Peritoneal Diseases
Suppuration
Abdominal Abscess
Peritonitis
Cholecystitis
Ceftriaxone
Intestinal Diseases
Pharmacologic Actions
Inflammation
Cecal Diseases
Digestive System Diseases
Radiation-Sensitizing Agents
Abscess

ClinicalTrials.gov processed this record on November 09, 2009