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

This study has been completed.
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT01097005
First received: February 26, 2010
Last updated: July 28, 2016
Last verified: March 2015

February 26, 2010
July 28, 2016
January 2009
March 2014   (final data collection date for primary outcome measure)
Bacilli Negative Conversion Rate [ Time Frame: During the treatment with clarithromycin, from 40 days to 1232 days ] [ Designated as safety issue: No ]
Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin
  • 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) ] [ Designated as safety issue: Yes ]
  • Rate of bacterial eradication [ Time Frame: When the absence of discharge of bacilli is confirmed (around 6 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01097005 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion
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) ] [ Designated as safety issue: No ]
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Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

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."

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Mycobacterium Infections, Atypical
Not Provided
Klaricid
Those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid

Exclusion Criteria

  • Contraindications according to the package insert
  • Patients with a history of hypersensitivity to any ingredient of Klaricid
  • Patients who are receiving pimozide, ergot-containing products, or cisapride
  • Patients who have AIDS (Acquired Immune Deficiency Syndrome)
Both
15 Years to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01097005
P10-765
No
Yes
Please contact the investigator, and discuss with us.
Mylan Inc.
Mylan Inc.
Taisho Pharmaceutical Co., Ltd.
Study Director: Jun Kato, MD., Ph.D. Abbott Japan Co.,Ltd
Mylan Inc.
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP