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

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00488306

Collaborator

(none)

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Abdominal Abscess	Drug: tigecycline	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.