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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097005
First Posted: April 1, 2010
Last Update Posted: September 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Mylan Inc.
  Purpose
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

Condition
Mycobacterium Infections, Atypical

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

Resource links provided by NLM:


Further study details as provided by Mylan Inc.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 466
Study Start Date: January 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Klaricid
Those with an exposure

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."

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

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


  Show 59 Study Locations
Sponsors and Collaborators
Mylan Inc.
Taisho Pharmaceutical Co., Ltd.
Investigators
Study Director: Jun Kato, MD., Ph.D. Abbott Japan Co.,Ltd
  More Information

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01097005     History of Changes
Other Study ID Numbers: P10-765
First Submitted: February 26, 2010
First Posted: April 1, 2010
Results First Submitted: June 17, 2015
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016
Last Verified: March 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Please contact the investigator, and discuss with us.

Keywords provided by Mylan Inc.:
Mycobacterium Infections, Atypical

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors