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

March 18, 2022 updated by: Mylan Inc.
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Site Reference ID/Investigator# 36460
      • Aichi, Japan
        • Site Reference ID/Investigator# 39122
      • Akita, Japan
        • Site Reference ID/Investigator# 36463
      • Ehime, Japan
        • Site Reference ID/Investigator# 36470
      • Fukuoka, Japan
        • Site Reference ID/Investigator# 36472
      • Fukuoka-shi, Japan
        • Site Reference ID/Investigator# 36471
      • Fukushima, Japan
        • Site Reference ID/Investigator# 36473
      • Gifu, Japan
        • Site Reference ID/Investigator# 36474
      • Hiroshima, Japan
        • Site Reference ID/Investigator# 36475
      • Hyogo, Japan
        • Site Reference ID/Investigator# 36482
      • Inzai, Japan
        • Site Reference ID/Investigator# 36465
      • Ishikawa, Japan
        • Site Reference ID/Investigator# 36483
      • Kagoshima, Japan
        • Site Reference ID/Investigator# 36484
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 36485
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 36486
      • Kanagawa, Japan
        • Site Reference ID/Investigator# 36487
      • Kitakyushu, Japan
        • Site Reference ID/Investigator# 54466
      • Kobe, Japan
        • Site Reference ID/Investigator# 54468
      • Kochi, Japan
        • Site Reference ID/Investigator# 36488
      • Kofu, Japan
        • Site Reference ID/Investigator# 36513
      • Kumamoto, Japan
        • Site Reference ID/Investigator# 39126
      • Kyoto, Japan
        • Site Reference ID/Investigator# 36489
      • Kyoto, Japan
        • Site Reference ID/Investigator# 36493
      • Kyoto, Japan
        • Site Reference ID/Investigator# 39123
      • Maebashi, Japan
        • Site Reference ID/Investigator# 54469
      • Miyagi, Japan
        • Site Reference ID/Investigator# 36494
      • Miyazaki, Japan
        • Site Reference ID/Investigator# 36495
      • Nagoya, Japan
        • Site Reference ID/Investigator# 36459
      • Nagoya, Japan
        • Site Reference ID/Investigator# 36461
      • Nara, Japan
        • Site Reference ID/Investigator# 54465
      • Obihiro, Japan
        • Site Reference ID/Investigator# 37145
      • Oita, Japan
        • Site Reference ID/Investigator# 36496
      • Okayama, Japan
        • Site Reference ID/Investigator# 36497
      • Okinawa, Japan
        • Site Reference ID/Investigator# 39125
      • Osaka, Japan
        • Site Reference ID/Investigator# 28404
      • Osaka, Japan
        • Site Reference ID/Investigator# 36492
      • Saitama, Japan
        • Site Reference ID/Investigator# 36501
      • Saitama, Japan
        • Site Reference ID/Investigator# 54464
      • Sapporo, Japan
        • Site Reference ID/Investigator# 36477
      • Sapporo, Japan
        • Site Reference ID/Investigator# 36478
      • Sapporo, Japan
        • Site Reference ID/Investigator# 36481
      • Seto, Japan
        • Site Reference ID/Investigator# 36462
      • Shimane, Japan
        • Site Reference ID/Investigator# 36503
      • Shimotsuke, Japan
        • Site Reference ID/Investigator# 36506
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 36504
      • Shizuoka, Japan
        • Site Reference ID/Investigator# 36505
      • Takatsuki, Japan
        • Site Reference ID/Investigator# 36499
      • Tokyo, Japan
        • Site Reference ID/Investigator# 15101
      • Tokyo, Japan
        • Site Reference ID/Investigator# 36507
      • Tokyo, Japan
        • Site Reference ID/Investigator# 36508
      • Tokyo, Japan
        • Site Reference ID/Investigator# 36509
      • Tokyo, Japan
        • Site Reference ID/Investigator# 36510
      • Tokyo, Japan
        • Site Reference ID/Investigator# 42710
      • Tokyo, Japan
        • Site Reference ID/Investigator# 54470
      • Toyohashi, Japan
        • Site Reference ID/Investigator# 36458
      • Wakayama, Japan
        • Site Reference ID/Investigator# 36511
      • Wakayama, Japan
        • Site Reference ID/Investigator# 37144
      • Yamaguchi, Japan
        • Site Reference ID/Investigator# 36512
      • Yamanashi, Japan
        • Site Reference ID/Investigator# 39124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Klaricid
Those with an exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the treatment with clarithromycin, from 40 days to 1232 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
When treatment with clarithromycin is discontinued, from 40 days to 1232 days
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Taisho Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Jun Kato, MD., Ph.D., Abbott Japan Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

April 1, 2010

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 18, 2022

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Please contact the investigator, and discuss with us.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mycobacterium Infections, Atypical

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe