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CompletedNCT00488306Updated Jul 7, 2009

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

A Phase 4 interventional study of tigecycline in Abdominal Abscess, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-07.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer (part of Pfizer) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Abdominal Abscess

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Keywords

  • Tigecycline
  • Complicated intra-abdominal infections
  • cIAI
03

In context

Abdominal Abscess

31 studies on the registry are indexed under Abdominal Abscess; 5 are open to participants now.

This study's enrollment of 50 is below the median of 105 across 24 interventional studies indexed under Abdominal Abscess.

Browse Abdominal Abscess studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 484 studies on the registry; none are open to participants now.

First submitted before Wyeth became part of Pfizer.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any malignancy to the abdomen with less than 6 months.
  • Anticipated length of antibiotic therapy less than 5 days.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • Multiple Cities, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00488306
First posted
Jun 20, 2007
Start date
Aug 2006
Completion
Aug 2007
Last update
Jul 7, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager
principal investigator · For Taiwan, medinfo@wyeth.com
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Tigecycline

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