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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598962
First Posted: January 23, 2008
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
January 11, 2008
January 23, 2008
May 23, 2017
December 1994
November 2006   (Final data collection date for primary outcome measure)
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: 6 months ]
neg cultures X3 ( sputum conversion)
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at three months, then at six months, then annually and prn for life ]
Complete list of historical versions of study NCT00598962 on ClinicalTrials.gov Archive Site
Microbiological cultures [ Time Frame: 1yr ]
neg culture 1 yr on treatment
Microbiological cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at three months, then at six months, then annually and prn for life ]
Not Provided
Not Provided
 
Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
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
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)
Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mycobacterium Avium Complex
  • Drug: Azithromycin
    Dosage dependent on clinical factors such as age, weight and patient-specific health status
    Other Name: Zithromax
  • Drug: Rifabutin/rifampin
    Other Name: mycobutin/
Experimental: azithromycin and rifabutin/rifampin
Azithromycin and rifabutin/rifampin administered three times weekly.
Interventions:
  • Drug: Azithromycin
  • Drug: Rifabutin/rifampin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
May 18, 2017
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00598962
426
No
Not Provided
Plan to Share IPD: No
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
The University of Texas Health Science Center at Tyler
Pfizer
Principal Investigator: Richard J Wallace Jr., M.D. The University of Texas Health Science Center at Tyler
The University of Texas Health Science Center at Tyler
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP