Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients

In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.

Study Overview

• Status: Completed
• Conditions: Abdominal Abscess
• Intervention / Treatment: Drug: tigecycline

Detailed Description

To evaluate the efficacy and safety of tigecycline to treat complicated intra-abdominal infections in hospitalized patients. Both the clinical response profile and the microbiological response profile will be assessed. The primary endpoint will be clinical response within the microbiological evaluable population at the test-of-cure assessment.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Multiple Cities, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospitalized male or female patients greater than or equal to 18 years of age.
• Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess.

• Patients with a complicated intra-abdominal infection such as:

  • an intra-abdominal abscess;
  • an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving > 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site.
  • appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess;
  • perforated diverticulitis complicated by abscess formation or fecal contamination;
  • complicated cholecystitis with evidence of perforation or empyema;
  • perforation of the large or small intestine with abscess, or fecal contamination;
  • purulent peritonitis or peritonitis associated with fecal contamination;
  • gastric or duodenal ulcer perforation with symptoms lasting at least 24 hours prior to operation;
  • traumatic bowel perforation with symptoms lasting at least 12 hours prior to operation.

Exclusion Criteria:

• Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
• Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months.
• Anticipated length of antibiotic therapy less than 5 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment.

Secondary Outcome Measures

Outcome Measure
microbiological response (eradicated, persistence, superinfection, or indeterminate) at the patient level, microbiological response (eradicated, persistence, or indeterminate) at the pathogen level (overall and resistant pathogens) clinical

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: June 18, 2007
• First Submitted That Met QC Criteria: June 18, 2007
• First Posted (Estimate): June 20, 2007

Study Record Updates

• Last Update Posted (Estimate): July 7, 2009
• Last Update Submitted That Met QC Criteria: July 6, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Tigecycline; cIAI; Complicated intra-abdominal infections
• Additional Relevant MeSH Terms: Infections; Suppuration; Abscess; Intraabdominal Infections; Abdominal Abscess; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Tigecycline
• Other Study ID Numbers: 3074A1-101994