Tigecycline for Treatment of Rapidly Growing Mycobacteria

This study is ongoing, but not recruiting participants.

First Received: January 14, 2008 No Updates Released

Sponsors and Collaborators:	The University of Texas Health Science Center at Tyler Wyeth
Information provided by:	The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:	NCT00600600

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 II

Drug Information available for: Tigecycline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment, Uncontrolled
Official Title:	Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)

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

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

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:	The University of Texas Health Science Center at Tyler ( Richard J. Wallace Jr. M.D. )
Study ID Numbers:	660
Study First Received:	January 14, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600600 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Respiratory Tract Diseases

Tigecycline
Lung Diseases
Mycobacterium Infections

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Tigecycline

Therapeutic Uses
Lung Diseases
Mycobacterium Infections
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on March 16, 2009