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

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Minocycline; Tigecycline

Criteria

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.