Clinical trial NCT01097005: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycobacterium Infections, Atypical
Keywords: Mycobacterium Infections, Atypical
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Taisho Pharmaceutical Co., Ltd.
First posted: 2010-04-01
Enrollment: 466
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid

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."

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)

Primary outcomes:
measure: Bacilli Negative Conversion Rate
timeFrame: During the treatment with clarithromycin, from 40 days to 1232 days
Secondary outcomes:
measure: Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
timeFrame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days
measure: Bacteriological Relapse Related to Duration of Clarithromycin Administration
timeFrame: 36 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 36460
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 39122
city: Akita
country: Japan
facility: Site Reference ID/Investigator# 36463
city: Ehime
country: Japan
facility: Site Reference ID/Investigator# 36470
city: Fukuoka-shi
country: Japan
facility: Site Reference ID/Investigator# 36471
city: Fukuoka
country: Japan
facility: Site Reference ID/Investigator# 36472
city: Fukushima
country: Japan
facility: Site Reference ID/Investigator# 36473
city: Gifu
country: Japan
facility: Site Reference ID/Investigator# 36474
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 36475
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 36482
city: Inzai
country: Japan
facility: Site Reference ID/Investigator# 36465
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 36483
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 36484
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 36485
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 36486
city: Kanagawa
country: Japan
facility: Site Reference ID/Investigator# 36487
city: Kitakyushu
country: Japan
facility: Site Reference ID/Investigator# 54466
city: Kobe
country: Japan
facility: Site Reference ID/Investigator# 54468
city: Kochi
country: Japan
facility: Site Reference ID/Investigator# 36488
city: Kofu
country: Japan
facility: Site Reference ID/Investigator# 36513
city: Kumamoto
country: Japan
facility: Site Reference ID/Investigator# 39126
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 36489
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 36493
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 39123
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 54469
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 36494
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 36495
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 36459
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 36461
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 54465
city: Obihiro
country: Japan
facility: Site Reference ID/Investigator# 37145
city: Oita
country: Japan
facility: Site Reference ID/Investigator# 36496
city: Okayama
country: Japan
facility: Site Reference ID/Investigator# 36497
city: Okinawa
country: Japan
facility: Site Reference ID/Investigator# 39125
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 28404
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 36492
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 36501
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 54464
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 36477
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 36478
city: Sapporo
country: Japan
facility: Site Reference ID/Investigator# 36481
city: Seto
country: Japan
facility: Site Reference ID/Investigator# 36462
city: Shimane
country: Japan
facility: Site Reference ID/Investigator# 36503
city: Shimotsuke
country: Japan
facility: Site Reference ID/Investigator# 36506
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 36504
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 36505
city: Takatsuki
country: Japan
facility: Site Reference ID/Investigator# 36499
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 15101
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36507
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36508
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36509
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 36510
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 42710
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 54470
city: Toyohashi
country: Japan
facility: Site Reference ID/Investigator# 36458
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 36511
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 37144
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 36512
city: Yamanashi
country: Japan
facility: Site Reference ID/Investigator# 39124
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Jun Kato, MD., Ph.D.
role: STUDY_DIRECTOR
References: