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

NCT ID: NCT01097005

Last Updated: 2022-03-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

466 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-03-31

Brief Summary

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To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

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Detailed Description

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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."

Conditions

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Mycobacterium Infections, Atypical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Klaricid

Those with an exposure

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taisho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Kato, MD., Ph.D.

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Site Reference ID/Investigator# 36460

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 39122

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 36463

Akita, , Japan

Site Status

Site Reference ID/Investigator# 36470

Ehime, , Japan

Site Status

Site Reference ID/Investigator# 36471

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 36472

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 36473

Fukushima, , Japan

Site Status

Site Reference ID/Investigator# 36474

Gifu, , Japan

Site Status

Site Reference ID/Investigator# 36475

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 36482

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 36465

Inzai, , Japan

Site Status

Site Reference ID/Investigator# 36483

Ishikawa, , Japan

Site Status

Site Reference ID/Investigator# 36484

Kagoshima, , Japan

Site Status

Site Reference ID/Investigator# 36485

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 36486

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 36487

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 54466

Kitakyushu, , Japan

Site Status

Site Reference ID/Investigator# 54468

Kobe, , Japan

Site Status

Site Reference ID/Investigator# 36488

Kochi, , Japan

Site Status

Site Reference ID/Investigator# 36513

Kofu, , Japan

Site Status

Site Reference ID/Investigator# 39126

Kumamoto, , Japan

Site Status

Site Reference ID/Investigator# 36489

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 36493

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 39123

Kyoto, , Japan

Site Status

Site Reference ID/Investigator# 54469

Maebashi, , Japan

Site Status

Site Reference ID/Investigator# 36494

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 36495

Miyazaki, , Japan

Site Status

Site Reference ID/Investigator# 36459

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 36461

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 54465

Nara, , Japan

Site Status

Site Reference ID/Investigator# 37145

Obihiro, , Japan

Site Status

Site Reference ID/Investigator# 36497

Okayama, , Japan

Site Status

Site Reference ID/Investigator# 39125

Okinawa, , Japan

Site Status

Site Reference ID/Investigator# 28404

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 36492

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 36496

Ōita, , Japan

Site Status

Site Reference ID/Investigator# 36501

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 54464

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 36477

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 36478

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 36481

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 36462

Seto, , Japan

Site Status

Site Reference ID/Investigator# 36503

Shimane, , Japan

Site Status

Site Reference ID/Investigator# 36506

Shimotsuke, , Japan

Site Status

Site Reference ID/Investigator# 36504

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 36505

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 36499

Takatsuki, , Japan

Site Status

Site Reference ID/Investigator# 15101

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36507

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36508

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36509

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36510

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 42710

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 54470

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 36458

Toyohashi, , Japan

Site Status

Site Reference ID/Investigator# 36511

Wakayama, , Japan

Site Status

Site Reference ID/Investigator# 37144

Wakayama, , Japan

Site Status

Site Reference ID/Investigator# 36512

Yamaguchi, , Japan

Site Status

Site Reference ID/Investigator# 39124

Yamanashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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P10-765

Identifier Type: -

Identifier Source: org_study_id

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