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Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081744
Recruitment Status : Completed
First Posted : April 21, 2004
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

Condition or disease Intervention/treatment Phase
Gram-Positive Bacterial Infections Cross Infection Drug: Tigecycline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 850 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects
Study Start Date : November 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms
  • Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline
  • Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics

Exclusion Criteria:

  • Subjects who are moribund with an expected survival of less than 2 weeks.
  • Subjects who have been designated as "Do Not Resuscitate", unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy
  • Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081744


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00081744    
Other Study ID Numbers: 3074A1-301
First Posted: April 21, 2004    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Bacterial Infections
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Intraabdominal Infections
Gram-Positive Bacterial Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Imipenem
Tigecycline
Cilastatin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors