Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

NCT00205816

Last updated date
Study Location
Heidelberg, , D-69120, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.

- Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.

- Patient must give informed consent.

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


- Patients with an expected survival of less than 2 weeks.


- Patients who have been designated as "Do Not Resuscitate".


- Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds
related to this class of antibacterial agents.


- Pregnant women or nursing mothers.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
Official Title  ICMJE An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
Brief Summary

The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Infections
Intervention  ICMJE Drug: Tigecycline
Study Arms  ICMJE Not Provided
Publications * Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.

*   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: February 7, 2013)
26
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
  • Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
  • Patient must give informed consent.

Exclusion Criteria:

  • Patients with an expected survival of less than 2 weeks.
  • Patients who have been designated as "Do Not Resuscitate".
  • Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
  • Pregnant women or nursing mothers.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 8 Years and older   (Child, 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 Germany,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205816
Other Study ID Numbers  ICMJE 3074A1-310
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
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
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP