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Clinical Trial Summary

To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.


Clinical Trial Description

Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America guidelines recommend a clarithromycin-based combination therapy for treatment of Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Objectives: To obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of MAC lung disease. Methods: In accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment." ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01097005
Study type Observational
Source Viatris Inc.
Contact
Status Completed
Phase
Start date January 2009
Completion date March 2014

See also
  Status Clinical Trial Phase
Completed NCT00001318 - Treatment of Non-Tuberculous Mycobacterial Infections With Interferon Gamma Phase 2