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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00488306
• Date of registration: 18/06/2007
• Prospective Registration: No
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI
• Scientific title: A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients
• Date of first enrolment: August 2006
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00488306
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

• Name: Trial Manager
• Affiliation: For Taiwan, [e-mail]

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Abdominal Abscess

Intervention(s)

Drug: tigecycline

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

3074A1-101994

Source(s) of Monetary Support

Please refer to primary and secondary sponsors