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

NCT00488306 | Completed Phase 4

• 1 other identifier: 3074A1-101994
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Abscess

Keywords

Tigecycline; Complicated intra-abdominal infections; cIAI

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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

Interventions

tigecycline DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Multiple Cities, Taiwan

Location

MeSH Terms

Conditions

Abdominal Abscess

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Abscess; Suppuration; Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Taiwan, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: August 1, 2006
• Study Completion: August 1, 2007
• Last Updated: July 7, 2009

Record last verified: 2009-07

Locations

TW (1)