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Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598897
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.
Collaborators:
Abbott
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
August 1995
August 7, 2002   (Final data collection date for primary outcome measure)
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: 6 months ]
sputum conversion culture neg x3
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ]
Complete list of historical versions of study NCT00598897 on ClinicalTrials.gov Archive Site
Clinical and microbiological outcomes [ Time Frame: 1 yr ]
culture neg 1 yr on treatment
To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ]
Not Provided
Not Provided
 
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week
Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mycobacterium Avium Complex Lung Disease
Drug: clarithromycin, rifabutin
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
Other Name: Biaxin, mycobutin
Experimental: clarithromycin and rifabutin/rifampin
Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.
Intervention: Drug: clarithromycin, rifabutin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
May 18, 2017
August 7, 2002   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet American Thoracic Society criteria for nontuberculous mycobacterial 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; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
  • Adults age 18 and older
  • Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

  • History of allergy to study drugs
  • If a mensruating female, not pregnant and on adequate birth control.
  • Children less than 18 years of age
  • HIV + or at high risk for HIV infection.
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
 
 
NCT00598897
447
No
Not Provided
Plan to Share IPD: No
Plan Description: No plan to share.
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
The University of Texas Health Science Center at Tyler
  • Abbott
  • 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