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

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.
 
ClinicalTrials.gov Identifier: NCT01097005
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Mylan Inc.

Tracking Information
First Submitted Date February 26, 2010
First Posted Date April 1, 2010
Results First Submitted Date June 17, 2015
Results First Posted Date September 19, 2016
Last Update Posted Date September 19, 2016
Study Start Date January 2009
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2016)
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
Original Primary Outcome Measures
 (submitted: March 30, 2010)
  • 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) ]
  • Rate of bacterial eradication [ Time Frame: When the absence of discharge of bacilli is confirmed (around 6 months) ]
Change History Complete list of historical versions of study NCT01097005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 28, 2016)
  • 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
Original Secondary Outcome Measures
 (submitted: March 30, 2010)
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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Official Title Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Brief Summary To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
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."

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Condition Mycobacterium Infections, Atypical
Intervention Not Provided
Study Groups/Cohorts Klaricid
Those with an exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 28, 2016)
466
Original Estimated Enrollment
 (submitted: March 30, 2010)
200
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01097005
Other Study ID Numbers P10-765
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Please contact the investigator, and discuss with us.
Responsible Party Mylan Inc.
Study Sponsor Mylan Inc.
Collaborators Taisho Pharmaceutical Co., Ltd.
Investigators
Study Director: Jun Kato, MD., Ph.D. Abbott Japan Co.,Ltd
PRS Account Mylan Inc.
Verification Date March 2015