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Tigecycline for Treatment of Rapidly Growing Mycobacteria

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00600600
First received: January 14, 2008
Last updated: May 19, 2017
Last verified: May 2017
  Purpose
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

Condition Intervention Phase
Mycobacterium Abscessus Lung Disease
Rapidly Growing Mycobacterial Lung Disease
Drug: Tigecycline
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)

Resource links provided by NLM:


Further study details as provided by Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler:

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


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


Enrollment: 8
Study Start Date: April 2002
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 14, 2008
Last Updated: May 19, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on May 25, 2017