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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 27, 2013
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: September 2013 (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

  Show 59 Study Locations
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 27, 2013
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 May 19, 2013