Tigecycline for Treatment of Rapidly Growing Mycobacteria

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Mycobacterium Abscessus Lung Disease; Rapidly Growing Mycobacterial Lung Disease

Treatments: Drug: Tigecycline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00600600

660

Details and patient eligibility

About

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

Full description

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

Enrollment: 8 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Tigecycline

Experimental group

Description:

tigecycline titrated dose according to patient age and clinical status

Treatment:

Drug: Tigecycline