Tigecycline for Treatment of Rapidly Growing Mycobacteria

Mycobacterium Abscessus Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600600
• Other study ID #: 660
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: May 19, 2017
• Start date: April 2002
• Est. completion date: December 2010

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center at Tyler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Abscessus Lung Disease
• Mycobacterium Infections
• Rapidly Growing Mycobacterial Lung Disease

Intervention

Drug:
• Tigecycline
Tigecycline dosage based on age and clinical status of patient.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at Tyler	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	culture neg X3 ( sputum conversion)	6 mos
Secondary	clinical and Microbiological outcomes	clinical and radiographic improvements	6 mos