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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
  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 ] [ 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


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 ] [ 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


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

Ages Eligible for Study:   15 Years to 99 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 26, 2010
Results First Received: June 17, 2015
Last Updated: July 28, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 30, 2016