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

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

Detailed 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.

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

Conditions
-----------------
Mycobacterium Infections, Atypical

Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Klaricid<br>Those with an exposure | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycobacterium Infections, Atypical