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Tigecycline for Treatment of Rapidly Growing Mycobacteria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The University of Texas Health Science Center at Tyler.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00600600
First received: January 14, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:

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

Further study details as provided by 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: Monthly while on treatment, then followup after therapy discontinuation will be evaluated monthly for one to two years or as deemed necessary ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological Cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be evaluated monthly for one to two years or as deemed necessary ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: April 2002
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Tigecycline
Standard dose Tigecycline 50 mg daily IV; however, daily dose may be dependent on clinical factors such as age, weight and patient-specific health status
Other Name: Tygacil

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

Responsible Party: Richard J. Wallace Jr. M.D., 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: January 14, 2008
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013