Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
|ClinicalTrials.gov Identifier: NCT01097005|
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
|Condition or disease|
|Mycobacterium Infections, Atypical|
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 Type :||Observational|
|Actual Enrollment :||466 participants|
|Official Title:||Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections|
|Study Start Date :||January 2009|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Those with an exposure
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097005
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|Study Director:||Jun Kato, MD., Ph.D.||Abbott Japan Co.,Ltd|