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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
  Purpose

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week


Condition Intervention Phase
Mycobacterium Avium Complex Lung Disease
 Drug: clarithromycin, rifabutin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at Tyler:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 89
Study Start Date: August 1995
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598897

Locations
United States, Texas
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
Sponsors and Collaborators
The University of Texas Health Science Center at Tyler
Abbott
Pfizer
Investigators
Principal Investigator: Richard J Wallace Jr., M.D. The University of Texas Health Science Center at Tyler
  More Information

No publications provided

Responsible Party: Richard J. Wallace Jr., M.D., The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier: NCT00598897     History of Changes
Other Study ID Numbers: 447
Study First Received: January 11, 2008
Last Updated: January 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at Tyler:
MAC

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Respiratory Tract Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Atypical
Clarithromycin
Rifabutin
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on May 21, 2013