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OpenTrials
Completed

NCT Number: NCT00598897

Use of Clarithromycin and Rifabutin 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

Completed

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Key information

Conditions

Mycobacterium Avium Complex Lung Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

About this study

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clarithromycin, rifabutin

Drug

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 names: Biaxin, mycobutin

Primary outcomes

  1. Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

    Time frame: 6 months

    sputum conversion culture neg x3

Secondary outcomes

  1. Clinical and microbiological outcomes

    Time frame: 1 yr

    culture neg 1 yr on treatment

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • Abbott
  • Pfizer

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
2002
Study completion
2017
First posted
Jan 23, 2008
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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