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Tigecycline for Treatment of Rapidly Growing Mycobacteria

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ClinicalTrials.gov Identifier: NCT00600600
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : May 23, 2017
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler

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
Mycobacterium Abscessus Lung Disease Rapidly Growing Mycobacterial Lung Disease Drug: Tigecycline 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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 : April 2002
Actual Primary Completion Date : April 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline
U.S. FDA Resources

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 Name: tygacil



Primary Outcome Measures :
  1. Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: 6 mos ]
    culture neg X3 ( sputum conversion)


Secondary Outcome Measures :
  1. clinical and Microbiological outcomes [ Time Frame: 6 mos ]
    clinical and radiographic improvements



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00600600


Locations
United States, Texas
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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     History of Changes
Other Study ID Numbers: 660
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tigecycline
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents