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Tigecycline for Treatment of Rapidly Growing Mycobacteria

Sponsor
The University of Texas Health Science Center at Tyler (Other)
Overall Status
Completed
CT.gov ID
NCT00600600
Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
8
Enrollment
1
Location
1
Arm
104
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tigecycline

tigecycline titrated dose according to patient age and clinical status

Drug: Tigecycline
Tigecycline dosage based on age and clinical status of patient.
Other Names:
  • tygacil

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [6 mos]

      culture neg X3 ( sputum conversion)

    Secondary Outcome Measures

    1. clinical and Microbiological outcomes [6 mos]

      clinical and radiographic improvements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Positive cultures for rapidly growing mycobacteria

    • Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs

    • Adults and children 10 years of age and older

    • Pretreatment isolate of M. avium complex available for MIC determination

    • Available for followup appointments

    Exclusion Criteria:

    • History of tetracycline allergy

    • If a menstruating female, not pregnant and on adequate birth control

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Tyler Tyler Texas United States 75708

    Sponsors and Collaborators

    • The University of Texas Health Science Center at Tyler
    • Wyeth is now a wholly owned subsidiary of Pfizer

    Investigators

    • Principal Investigator: Richard J Wallace Jr., M.D., The University of Texas Health Science Center at Tyler

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler
    ClinicalTrials.gov Identifier:
    NCT00600600
    Other Study ID Numbers:
    • 660
    First Posted:
    Jan 25, 2008
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Mycobacterium Infections
    Lung Diseases
    Tigecycline

    Study Results

    No Results Posted as of May 23, 2017