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

Mylan Inc.466 enrolled

Overview

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

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."

Study Type

OBSERVATIONAL

Enrollment

466

Conditions

Mycobacterium Infections, Atypical

Eligibility

Sex: ALLMin age: 15 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Locations (59)

Outcomes

Primary Outcomes

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

Time frame: During the treatment with clarithromycin, from 40 days to 1232 days

Secondary Outcomes

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")

Time frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days

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

Time frame: 36 months

Data from ClinicalTrials.gov

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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# 36471

Fukuoka, Japan

Site Reference ID/Investigator# 36472

Fukuoka, 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

Hyōgo, Japan

...and 49 more locations