Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01097005
First received: February 26, 2010
Last updated: May 22, 2014
Last verified: May 2014

February 26, 2010
May 22, 2014
January 2009
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01097005 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Mycobacterium Infections, Atypical
Not Provided
Klaricid
Those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
March 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01097005
P10-765
Not Provided
Abbott
Abbott
Taisho Pharmaceutical Co., Ltd.
Study Director: Jun Kato, MD., Ph.D. Abbott Japan Co.,Ltd
Abbott
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP