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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin
Sponsor: The University of Texas Health Science Center at Tyler

Current Primary Outcome: 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 ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

Original Secondary Outcome: 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 ]

Information By: The University of Texas Health Science Center at Tyler

Dates:
Date Received: January 11, 2008
Date Started: August 1995
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017