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

Mycobacterium Infections, Atypical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097005
• Other study ID #: P10-765
• Status: Completed
• Start date: January 2009
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Mycobacterium Infections
• Mycobacterium Infections, Atypical
• Mycobacterium Infections, Nontuberculous

Locations

Country	Name	City	State
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# 36486	Kanagawa
Japan	Site Reference ID/Investigator# 36487	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# 36489	Kyoto
Japan	Site Reference ID/Investigator# 36493	Kyoto
Japan	Site Reference ID/Investigator# 39123	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# 28404	Osaka
Japan	Site Reference ID/Investigator# 36492	Osaka
Japan	Site Reference ID/Investigator# 36501	Saitama
Japan	Site Reference ID/Investigator# 54464	Saitama
Japan	Site Reference ID/Investigator# 36477	Sapporo
Japan	Site Reference ID/Investigator# 36478	Sapporo
Japan	Site Reference ID/Investigator# 36481	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# 15101	Tokyo
Japan	Site Reference ID/Investigator# 36507	Tokyo
Japan	Site Reference ID/Investigator# 36508	Tokyo
Japan	Site Reference ID/Investigator# 36509	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

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Taisho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacilli Negative Conversion Rate	Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin	During the treatment with clarithromycin, from 40 days to 1232 days
Secondary	Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator	Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")	When treatment with clarithromycin is discontinued, from 40 days to 1232 days
Secondary	Bacteriological Relapse Related to Duration of Clarithromycin Administration	Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion	36 months