Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
- Conditions
- Mycobacterium Infections, Atypical
- Registration Number
- NCT01097005
- Lead Sponsor
- Mylan Inc.
- 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."
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 466
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacilli Negative Conversion Rate 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
- Secondary Outcome Measures
Name Time Method Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator 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 36 months Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion
Trial Locations
- Locations (59)
Site Reference ID/Investigator# 36482
🇯🇵Hyogo, Japan
Site Reference ID/Investigator# 36465
🇯🇵Inzai, Japan
Site Reference ID/Investigator# 36483
🇯🇵Ishikawa, Japan
Site Reference ID/Investigator# 36460
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 36463
🇯🇵Akita, Japan
Site Reference ID/Investigator# 36471
🇯🇵Fukuoka-shi, Japan
Site Reference ID/Investigator# 36473
🇯🇵Fukushima, Japan
Site Reference ID/Investigator# 36475
🇯🇵Hiroshima, Japan
Site Reference ID/Investigator# 36484
🇯🇵Kagoshima, Japan
Site Reference ID/Investigator# 36485
🇯🇵Kanagawa, Japan
Site Reference ID/Investigator# 54468
🇯🇵Kobe, Japan
Site Reference ID/Investigator# 54466
🇯🇵Kitakyushu, Japan
Site Reference ID/Investigator# 36497
🇯🇵Okayama, Japan
Site Reference ID/Investigator# 36492
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 39123
🇯🇵Kyoto, Japan
Site Reference ID/Investigator# 37145
🇯🇵Obihiro, Japan
Site Reference ID/Investigator# 39125
🇯🇵Okinawa, Japan
Site Reference ID/Investigator# 36477
🇯🇵Sapporo, Japan
Site Reference ID/Investigator# 36462
🇯🇵Seto, Japan
Site Reference ID/Investigator# 36504
🇯🇵Shizuoka, Japan
Site Reference ID/Investigator# 15101
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36508
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36459
🇯🇵Nagoya, Japan
Site Reference ID/Investigator# 36461
🇯🇵Nagoya, Japan
Site Reference ID/Investigator# 54465
🇯🇵Nara, Japan
Site Reference ID/Investigator# 36501
🇯🇵Saitama, Japan
Site Reference ID/Investigator# 54464
🇯🇵Saitama, Japan
Site Reference ID/Investigator# 36478
🇯🇵Sapporo, Japan
Site Reference ID/Investigator# 36509
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 42710
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36510
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36472
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 36474
🇯🇵Gifu, Japan
Site Reference ID/Investigator# 39122
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 36486
🇯🇵Kanagawa, Japan
Site Reference ID/Investigator# 36470
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 36487
🇯🇵Kanagawa, Japan
Site Reference ID/Investigator# 39126
🇯🇵Kumamoto, Japan
Site Reference ID/Investigator# 54469
🇯🇵Maebashi, Japan
Site Reference ID/Investigator# 36488
🇯🇵Kochi, Japan
Site Reference ID/Investigator# 36513
🇯🇵Kofu, Japan
Site Reference ID/Investigator# 36489
🇯🇵Kyoto, Japan
Site Reference ID/Investigator# 36493
🇯🇵Kyoto, Japan
Site Reference ID/Investigator# 36503
🇯🇵Shimane, Japan
Site Reference ID/Investigator# 36495
🇯🇵Miyazaki, Japan
Site Reference ID/Investigator# 36506
🇯🇵Shimotsuke, Japan
Site Reference ID/Investigator# 36499
🇯🇵Takatsuki, Japan
Site Reference ID/Investigator# 36507
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36496
🇯🇵Oita, Japan
Site Reference ID/Investigator# 28404
🇯🇵Osaka, Japan
Site Reference ID/Investigator# 36481
🇯🇵Sapporo, Japan
Site Reference ID/Investigator# 54470
🇯🇵Tokyo, Japan
Site Reference ID/Investigator# 36511
🇯🇵Wakayama, Japan
Site Reference ID/Investigator# 36512
🇯🇵Yamaguchi, Japan
Site Reference ID/Investigator# 39124
🇯🇵Yamanashi, Japan
Site Reference ID/Investigator# 36494
🇯🇵Miyagi, Japan
Site Reference ID/Investigator# 36505
🇯🇵Shizuoka, Japan
Site Reference ID/Investigator# 36458
🇯🇵Toyohashi, Japan
Site Reference ID/Investigator# 37144
🇯🇵Wakayama, Japan