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| Name | Class |
|---|---|
| Taisho Pharmaceutical Co., Ltd. | INDUSTRY |
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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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Klaricid | Those with an exposure |
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| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
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| Name | Affiliation | Role |
|---|---|---|
| Jun Kato, MD., Ph.D. | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 36460 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 39122 |
Please contact the investigator, and discuss with us.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clarithromycin | Those with an exposure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| 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 |
| 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# 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# 36496 | Ōita | 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 | Japan |
| Analysis of Safety |
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| Analysis of NTM Lung Disease |
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| Analysis of Bacilli Negative Conversion |
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| Analysis of CGI |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Clarithromycin | Those with an exposure |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Analysis of the bacilli negative conversion | Posted | Number | participants | 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") | Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale. | Posted | Number | Number of patients | 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 | End of study (completers). Analysis of bacteriological relapse. | Posted | Number | participants | 36 months |
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During treatment with clarithromycin up to 3.4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clarithromycin | Those with an exposure | 35 | 441 | 0 | 441 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Disorientation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Nephrotic syndrome | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Weight decreased | Investigations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "possible" by the investigator. |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Bacterial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Pneumonia bacterial | Infections and infestations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Atypical mycobacterial infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Anti-neutrophil cytoplasmic antibody positive vasculitis | Immune system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Loss of consciousness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Optic neuritis | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Arrhythmia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Cardiac failure acute | Cardiac disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Alveoliltis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Calculus urinary | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Haematuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment | Causal relationship with the study drug was rated as "Not related" by the investigator. |
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The investigators will be granted by sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Takao Miki, Medical Affairs | Mylan EPD Japan | takao.miki@mylan.com |
| ID | Term |
|---|---|
| D009165 | Mycobacterium Infections, Nontuberculous |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Title | Measurements |
|---|---|
|
| >=75 years |
|
| unknown |
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| unknown |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 0-14 months CLR |
| |||||
| ≥15 months CLR |
|