Mycobacterium Infections, Atypical
Conditions
Keywords
Mycobacterium Infections, Atypical
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.
Interventions
None listed
Sponsors
Taisho Pharmaceutical Co., Ltd.
Mylan Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacilli Negative Conversion Rate | During the treatment with clarithromycin, from 40 days to 1232 days | Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator | When treatment with clarithromycin is discontinued, from 40 days to 1232 days | Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales (Effective, Ineffective, Deterioration, Impossible) |
| Bacteriological Relapse Related to Duration of Clarithromycin Administration | 36 months | Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion |
Countries
Japan
Participant flow
Recruitment details
Patients will be registered using a central registration system. The investigators will register eligible patients with the registration center via FAX by 7 days after initiation of clarithromycin treatment.
Participants by arm
| Arm | Count |
|---|---|
| Clarithromycin Those with an exposure | 340 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Case Report Form not collected | 18 |
| Overall Study | Deviation from exclusion criteria | 37 |
| Overall Study | Discontinuance by complication | 50 |
| Overall Study | No examination data available | 244 |
| Overall Study | Poor medication compliance | 1 |
| Overall Study | Subjects cannot visit the hospital | 1 |
Baseline characteristics
| Characteristic | Clarithromycin |
|---|---|
| Age, Customized 45-64 years | 136 participants |
| Age, Customized <45 years | 15 participants |
| Age, Customized 65-74 years | 126 participants |
| Age, Customized >=75 years | 62 participants |
| Age, Customized unknown | 1 participants |
| Sex/Gender, Customized Female | 256 participants |
| Sex/Gender, Customized Male | 83 participants |
| Sex/Gender, Customized unknown | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 441 |
| serious Total, serious adverse events | 35 / 441 |
Outcome results
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
Time frame: During the treatment with clarithromycin, from 40 days to 1232 days
Population: Analysis of the bacilli negative conversion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clarithromycin | Bacilli Negative Conversion Rate | 269 participants |
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
Time frame: 36 months
Population: End of study (completers). Analysis of bacteriological relapse.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clarithromycin | Bacteriological Relapse Related to Duration of Clarithromycin Administration | 0-14 months CLR | 5 participants |
| Clarithromycin | Bacteriological Relapse Related to Duration of Clarithromycin Administration | ≥15 months CLR | 0 participants |
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)
Time frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days
Population: Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Clarithromycin | Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator | Impossible to assess | 9 Number of patients |
| Clarithromycin | Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator | Effective | 217 Number of patients |
| Clarithromycin | Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator | Ineffective | 13 Number of patients |
| Clarithromycin | Efficacy Evaluation Using the 4-rank Scale of Effective, Ineffective, Deterioration, or Impossible by the Investigator | Deterioration | 10 Number of patients |