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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:

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."


Sponsor: Mylan Inc.

Current Primary Outcome: Bacilli Negative Conversion Rate [ Time Frame: During the treatment with clarithromycin, from 40 days to 1232 days ]

Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin


Original Primary Outcome:

  • Evaluation of adverse event (occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Klaricid) [ Time Frame: During treatment with Klaricid, and six months after discontinuation of treatment (around 2 years) ]
  • Rate of bacterial eradication [ Time Frame: When the absence of discharge of bacilli is confirmed (around 6 months) ]


Current Secondary Outcome:

  • Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator [ Time Frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days ]
    Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")
  • Bacteriological Relapse Related to Duration of Clarithromycin Administration [ Time Frame: 36 months ]
    Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion


Original Secondary Outcome: Efficacy Evaluation using the 4-rank scale of "effective", "ineffective", "harmful", or "impossible" by the investigator [ Time Frame: When treatment with Klaricid is discontinued (around 18 months) ]

Information By: Mylan Inc.

Dates:
Date Received: February 26, 2010
Date Started: January 2009
Date Completion:
Last Updated: July 28, 2016
Last Verified: March 2015