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Trial record 25 of 402 for:    CLARITHROMYCIN

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

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.
 
ClinicalTrials.gov Identifier: NCT00598897
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
Abbott
Pfizer
Information provided by (Responsible Party):
Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler

Tracking Information
First Submitted Date  ICMJE January 11, 2008
First Posted Date  ICMJE January 23, 2008
Last Update Posted Date May 23, 2017
Actual Study Start Date  ICMJE August 1995
Actual Primary Completion Date August 7, 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: 6 months ]
sputum conversion culture neg x3
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2017)
Clinical and microbiological outcomes [ Time Frame: 1 yr ]
culture neg 1 yr on treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Official Title  ICMJE 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
Brief Summary To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week
Detailed Description Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mycobacterium Avium Complex Lung Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: clarithromycin and rifabutin/rifampin
Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.
Intervention: Drug: clarithromycin, rifabutin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2008)
89
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2017
Actual Primary Completion Date August 7, 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00598897
Other Study ID Numbers  ICMJE 447
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share.
Responsible Party Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
Study Sponsor  ICMJE The University of Texas Health Science Center at Tyler
Collaborators  ICMJE
  • Abbott
  • Pfizer
Investigators  ICMJE
Principal Investigator: Richard J Wallace Jr., M.D. The University of Texas Health Science Center at Tyler
PRS Account The University of Texas Health Science Center at Tyler
Verification Date May 2017

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