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

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ClinicalTrials.gov Identifier: NCT00195351
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : June 10, 2009
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis Drug: tigecycline Drug: ceftriaxone sodium + metronidazole Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Active Comparator: A Drug: tigecycline
every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

Active Comparator: B 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.




Primary Outcome Measures :
  1. Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]
    The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.


Secondary Outcome Measures :
  1. Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]
    The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.

  2. Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit. [ Time Frame: 10-21 days after the last dose of test article ]
    Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195351


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Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00195351     History of Changes
Other Study ID Numbers: 3074A1-400
First Posted: September 19, 2005    Key Record Dates
Results First Posted: June 10, 2009
Last Update Posted: February 25, 2013
Last Verified: February 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Complicated intra-abdominal infection
Appendicitis with abscess
Perforated diverticulitis
Purulent peritonitis
Complicated cholecystitis
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Appendicitis
Peritonitis
Diverticulitis
Intraabdominal Infections
Cross Infection
Cholecystitis
Acalculous Cholecystitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Peritoneal Diseases
Diverticular Diseases
Gallbladder Diseases
Biliary Tract Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Metronidazole
Ceftriaxone
Tigecycline
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors