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

Tracking Information

First Received Date ^ICMJE

January 14, 2008

Last Updated Date

January 14, 2008

Start Date ^ICMJE

April 2002

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tigecycline for Treatment of Rapidly Growing Mycobacteria

Official Title ^ICMJE

Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mycobacterium Abscessus Lung Disease
Rapidly Growing Mycobacterial Lung Disease

Intervention ^ICMJE

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

Study Arm (s)

Intervention: Drug: Tigecycline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00600600

Other Study ID Numbers ^ICMJE

660

Has Data Monitoring Committee

Responsible Party

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

Study Sponsor ^ICMJE

The University of Texas Health Science Center at Tyler

Collaborators ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators ^ICMJE

Principal Investigator:

Richard J Wallace Jr., M.D.

The University of Texas Health Science Center at Tyler

Information Provided By

The University of Texas Health Science Center at Tyler

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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