Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

Mycobacterium Avium Complex Clinical Trial

Official title:

Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598962
• Other study ID #: 426
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: May 19, 2017
• Start date: December 1994
• Est. completion date: May 18, 2017

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 and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

Description:

Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 18, 2017
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).

• Age 18 and older

• Pretreatment isolate of M. avium complex available for MIC determination

• Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination

• Available for long term followup

Exclusion Criteria:

• History of macrolide or rifamycins allergy

• Laboratory evidence of mycobacterial resistance to azithromycin

• Children less than 18 years of age

• If a menstruating female, not pregnant and on adequate birth control

• HIV+ or at risk

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Avium Complex
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Azithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
• Rifabutin/rifampin

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	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	neg cultures X3 ( sputum conversion)	6 months
Secondary	Microbiological cultures	neg culture 1 yr on treatment	1yr