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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01097005
First received: February 26, 2010
Last updated: March 3, 2014
Last verified: February 2014
  Purpose

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


Condition
Mycobacterium Infections, Atypical

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • Rate of bacterial eradication [ Time Frame: When the absence of discharge of bacilli is confirmed (around 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: January 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Klaricid
Those with an exposure

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097005

  Hide Study Locations
Locations
Japan
Site Reference ID/Investigator# 36460
Aichi, Japan
Site Reference ID/Investigator# 39122
Aichi, Japan
Site Reference ID/Investigator# 36463
Akita, Japan
Site Reference ID/Investigator# 36470
Ehime, Japan
Site Reference ID/Investigator# 36472
Fukuoka, Japan
Site Reference ID/Investigator# 36471
Fukuoka-shi, Japan
Site Reference ID/Investigator# 36473
Fukushima, Japan
Site Reference ID/Investigator# 36474
Gifu, Japan
Site Reference ID/Investigator# 36475
Hiroshima, Japan
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# 36484
Kagoshima, Japan
Site Reference ID/Investigator# 36485
Kanagawa, Japan
Site Reference ID/Investigator# 36487
Kanagawa, Japan
Site Reference ID/Investigator# 36486
Kanagawa, Japan
Site Reference ID/Investigator# 54466
Kitakyushu, Japan
Site Reference ID/Investigator# 54468
Kobe, Japan
Site Reference ID/Investigator# 36488
Kochi, Japan
Site Reference ID/Investigator# 36513
Kofu, Japan
Site Reference ID/Investigator# 39126
Kumamoto, Japan
Site Reference ID/Investigator# 39123
Kyoto, Japan
Site Reference ID/Investigator# 36493
Kyoto, Japan
Site Reference ID/Investigator# 36489
Kyoto, Japan
Site Reference ID/Investigator# 54469
Maebashi, Japan
Site Reference ID/Investigator# 36494
Miyagi, Japan
Site Reference ID/Investigator# 36495
Miyazaki, 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# 37145
Obihiro, Japan
Site Reference ID/Investigator# 36496
Oita, Japan
Site Reference ID/Investigator# 36497
Okayama, Japan
Site Reference ID/Investigator# 39125
Okinawa, Japan
Site Reference ID/Investigator# 36492
Osaka, Japan
Site Reference ID/Investigator# 28404
Osaka, Japan
Site Reference ID/Investigator# 54464
Saitama, Japan
Site Reference ID/Investigator# 36501
Saitama, Japan
Site Reference ID/Investigator# 36481
Sapporo, Japan
Site Reference ID/Investigator# 36477
Sapporo, Japan
Site Reference ID/Investigator# 36478
Sapporo, Japan
Site Reference ID/Investigator# 36462
Seto, Japan
Site Reference ID/Investigator# 36503
Shimane, Japan
Site Reference ID/Investigator# 36506
Shimotsuke, Japan
Site Reference ID/Investigator# 36504
Shizuoka, Japan
Site Reference ID/Investigator# 36505
Shizuoka, Japan
Site Reference ID/Investigator# 36499
Takatsuki, Japan
Site Reference ID/Investigator# 36508
Tokyo, Japan
Site Reference ID/Investigator# 36509
Tokyo, Japan
Site Reference ID/Investigator# 15101
Tokyo, Japan
Site Reference ID/Investigator# 36507
Tokyo, Japan
Site Reference ID/Investigator# 36510
Tokyo, Japan
Site Reference ID/Investigator# 42710
Tokyo, Japan
Site Reference ID/Investigator# 54470
Tokyo, Japan
Site Reference ID/Investigator# 36458
Toyohashi, Japan
Site Reference ID/Investigator# 36511
Wakayama, Japan
Site Reference ID/Investigator# 37144
Wakayama, Japan
Site Reference ID/Investigator# 36512
Yamaguchi, Japan
Site Reference ID/Investigator# 39124
Yamanashi, Japan
Sponsors and Collaborators
Abbott
Taisho Pharmaceutical Co., Ltd.
Investigators
Study Director: Jun Kato, MD., Ph.D. Abbott Japan Co.,Ltd
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01097005     History of Changes
Other Study ID Numbers: P10-765
Study First Received: February 26, 2010
Last Updated: March 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Mycobacterium Infections, Atypical

Additional relevant MeSH terms:
Mycobacterium Infections
Mycobacterium Infections, Atypical
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014