Abdominal Abscess Clinical Trial
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
In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary efficacy endpoint will be clinical response within the clinically evaluable population at the test-of-cure assessment. | |||
Secondary | 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 |
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