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

Purpose

This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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 Cross Infection Diverticulitis Peritonitis	Drug: tigecycline Drug: ceftriaxone sodium + metronidazole	Phase IV

MedlinePlus related topics:

Appendicitis Diverticulosis and Diverticulitis

ChemIDplus related topics:

Ceftriaxone Ceftriaxone Sodium Tigecycline Metronidazole Metronidazole hydrochloride Metronidazole phosphate

U.S. FDA Resources

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

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:

Clinical Response in the microbiologically evaluable population [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
Microbiological Response at the subject and pathogen levels [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]
Overall Response defined as a combination of the Clinical Response and the Microbiological Response at the subject level [ Time Frame: 10-21 days after the last dose of test article ] [ Designated as safety issue: No ]

Estimated Enrollment:	430
Study Start Date:	September 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 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 sodium + 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 over 100.4°F (38.0°C) or high white blood cell count 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: NCT00195351

Show 67 Study Locations

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074A1-400
First Received:	September 12, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00195351
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

Keywords provided by Wyeth:

Complicated intra-abdominal infection

Appendicitis with abscess

Perforated diverticulitis

Purulent peritonitis

Complicated cholecystitis

Study placed in the following topic categories:

Gallbladder Diseases

Metronidazole

Tigecycline

Gastrointestinal Diseases

Peritonitis

Cholecystitis

Ceftriaxone

Intestinal Diseases

Diverticulitis

Digestive System Diseases

Acalculous Cholecystitis

Abscess

Appendicitis

Biliary Tract Diseases

Peritoneal Diseases

Gastroenteritis

Cross Infection

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Communicable Diseases

Antiparasitic Agents

Antiprotozoal Agents

Pathologic Processes

Radiation-Sensitizing Agents

Therapeutic Uses

Physiological Effects of Drugs

Infection

Pharmacologic Actions

Cecal Diseases

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195351