Overview

This trial is active, not recruiting.

Conditions mycobacterium abscessus lung disease, rapidly growing mycobacterial lung disease
Treatment tigecycline
Phase phase 2
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Wyeth is now a wholly owned subsidiary of Pfizer
Start date April 2002
End date April 2010
Trial size 8 participants
Trial identifier NCT00600600, 660

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
tigecycline Tygacil
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

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 10 years old.

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

Additional Information

Official title Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
Principal investigator Richard J Wallace Jr., M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at Tyler.