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

Primary Purpose

Mycobacterium Avium Complex

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azithromycin
Rifabutin/rifampin
Sponsored by
The University of Texas Health Science Center at Tyler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium Complex focused on measuring MAC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Tyler

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

azithromycin and rifabutin/rifampin

Arm Description

Azithromycin and rifabutin/rifampin administered three times weekly.

Outcomes

Primary Outcome Measures

Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
neg cultures X3 ( sputum conversion)

Secondary Outcome Measures

Microbiological cultures
neg culture 1 yr on treatment

Full Information

First Posted
January 11, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00598962
Brief Title
Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 1994 (Actual)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium Complex
Keywords
MAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azithromycin and rifabutin/rifampin
Arm Type
Experimental
Arm Description
Azithromycin and rifabutin/rifampin administered three times weekly.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Intervention Type
Drug
Intervention Name(s)
Rifabutin/rifampin
Other Intervention Name(s)
mycobutin/
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Description
neg cultures X3 ( sputum conversion)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological cultures
Description
neg culture 1 yr on treatment
Time Frame
1yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace Jr., M.D.
Organizational Affiliation
The University of Texas Health Science Center at Tyler
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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