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

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Multiple Cities, , Taiwan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Abdominal Abscess
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00488306
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

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Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI
Official Title  ICMJE A Multicenter, Open Label Study to Evaluate the Efficacy and Safety of Tigecycline to Treat Complicated Intra-Abdominal Infections (cIAI) in Hospitalized Patients
Brief SummaryIn light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
Detailed DescriptionTo 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Abscess
Intervention  ICMJE Drug: tigecycline
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2007)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00488306
Other Study ID Numbers  ICMJE 3074A1-101994
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Taiwan, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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