NCT01097005

Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 466 (actual)
• Sponsor: Mylan Inc. · Industry
• Sex: All
• Age: 15 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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."

Conditions

• Mycobacterium Infections, Atypical

Timeline

• Start date: 2009-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-04-01
• Last updated: 2022-03-31
• Results posted: 2016-09-19

Locations

59 sites across 1 country: Japan