Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
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|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|
|Actual Primary Completion Date :||March 2014|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|