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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The University of Texas Health Science Center at Tyler.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Abbott
Pfizer
Information provided by:
The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00598897
First received: January 11, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 11, 2008
January 11, 2008
August 1995
July 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: Yes ]
Same as current
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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.
Other Names:
  • Biaxin
  • Mycobutin
1
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.
 
Active, not recruiting
89
Not Provided
July 2010   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00598897
447
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
  • 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
January 2008

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