Azithromycin in the Treatment of M. Avium Complex Lung Disease

Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Study Overview

• Status: Completed
• Conditions: Mycobacterium Avium Complex Lung Disease
• Intervention / Treatment: Drug: Azithromycin

Detailed Description

To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Tyler, Texas, United States, 75708
      • The University of Texas Health Science Center at Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• History of macrolide allergy
• Received macrolide therapy in last two months
• Children less than 18 years of age
• If a menstruating female, not pregnant and on adequate birth control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azithromycin; Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease	Drug: Azithromycin; Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors; Other Names: Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	neg cultures X3( sputum conversion)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological cultures	culture neg 1 yr on treatment	1yr

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at Tyler
• Collaborators: Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 1993
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (Estimate): January 23, 2008

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: MAC
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Lung Diseases; Mycobacterium avium-intracellulare Infection; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No