Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Study Details
Study Description
Brief Summary
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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."
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Klaricid Those with an exposure |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Site Reference ID/Investigator# 36460 | Aichi | Japan | ||
2 | Site Reference ID/Investigator# 39122 | Aichi | Japan | ||
3 | Site Reference ID/Investigator# 36463 | Akita | Japan | ||
4 | Site Reference ID/Investigator# 36470 | Ehime | Japan | ||
5 | Site Reference ID/Investigator# 36471 | Fukuoka-shi | Japan | ||
6 | Site Reference ID/Investigator# 36472 | Fukuoka | Japan | ||
7 | Site Reference ID/Investigator# 36473 | Fukushima | Japan | ||
8 | Site Reference ID/Investigator# 36474 | Gifu | Japan | ||
9 | Site Reference ID/Investigator# 36475 | Hiroshima | Japan | ||
10 | Site Reference ID/Investigator# 36482 | Hyogo | Japan | ||
11 | Site Reference ID/Investigator# 36465 | Inzai | Japan | ||
12 | Site Reference ID/Investigator# 36483 | Ishikawa | Japan | ||
13 | Site Reference ID/Investigator# 36484 | Kagoshima | Japan | ||
14 | Site Reference ID/Investigator# 36485 | Kanagawa | Japan | ||
15 | Site Reference ID/Investigator# 36486 | Kanagawa | Japan | ||
16 | Site Reference ID/Investigator# 36487 | Kanagawa | Japan | ||
17 | Site Reference ID/Investigator# 54466 | Kitakyushu | Japan | ||
18 | Site Reference ID/Investigator# 54468 | Kobe | Japan | ||
19 | Site Reference ID/Investigator# 36488 | Kochi | Japan | ||
20 | Site Reference ID/Investigator# 36513 | Kofu | Japan | ||
21 | Site Reference ID/Investigator# 39126 | Kumamoto | Japan | ||
22 | Site Reference ID/Investigator# 36489 | Kyoto | Japan | ||
23 | Site Reference ID/Investigator# 36493 | Kyoto | Japan | ||
24 | Site Reference ID/Investigator# 39123 | Kyoto | Japan | ||
25 | Site Reference ID/Investigator# 54469 | Maebashi | Japan | ||
26 | Site Reference ID/Investigator# 36494 | Miyagi | Japan | ||
27 | Site Reference ID/Investigator# 36495 | Miyazaki | Japan | ||
28 | Site Reference ID/Investigator# 36459 | Nagoya | Japan | ||
29 | Site Reference ID/Investigator# 36461 | Nagoya | Japan | ||
30 | Site Reference ID/Investigator# 54465 | Nara | Japan | ||
31 | Site Reference ID/Investigator# 37145 | Obihiro | Japan | ||
32 | Site Reference ID/Investigator# 36496 | Oita | Japan | ||
33 | Site Reference ID/Investigator# 36497 | Okayama | Japan | ||
34 | Site Reference ID/Investigator# 39125 | Okinawa | Japan | ||
35 | Site Reference ID/Investigator# 28404 | Osaka | Japan | ||
36 | Site Reference ID/Investigator# 36492 | Osaka | Japan | ||
37 | Site Reference ID/Investigator# 36501 | Saitama | Japan | ||
38 | Site Reference ID/Investigator# 54464 | Saitama | Japan | ||
39 | Site Reference ID/Investigator# 36477 | Sapporo | Japan | ||
40 | Site Reference ID/Investigator# 36478 | Sapporo | Japan | ||
41 | Site Reference ID/Investigator# 36481 | Sapporo | Japan | ||
42 | Site Reference ID/Investigator# 36462 | Seto | Japan | ||
43 | Site Reference ID/Investigator# 36503 | Shimane | Japan | ||
44 | Site Reference ID/Investigator# 36506 | Shimotsuke | Japan | ||
45 | Site Reference ID/Investigator# 36504 | Shizuoka | Japan | ||
46 | Site Reference ID/Investigator# 36505 | Shizuoka | Japan | ||
47 | Site Reference ID/Investigator# 36499 | Takatsuki | Japan | ||
48 | Site Reference ID/Investigator# 15101 | Tokyo | Japan | ||
49 | Site Reference ID/Investigator# 36507 | Tokyo | Japan | ||
50 | Site Reference ID/Investigator# 36508 | Tokyo | Japan | ||
51 | Site Reference ID/Investigator# 36509 | Tokyo | Japan | ||
52 | Site Reference ID/Investigator# 36510 | Tokyo | Japan | ||
53 | Site Reference ID/Investigator# 42710 | Tokyo | Japan | ||
54 | Site Reference ID/Investigator# 54470 | Tokyo | Japan | ||
55 | Site Reference ID/Investigator# 36458 | Toyohashi | Japan | ||
56 | Site Reference ID/Investigator# 36511 | Wakayama | Japan | ||
57 | Site Reference ID/Investigator# 37144 | Wakayama | Japan | ||
58 | Site Reference ID/Investigator# 36512 | Yamaguchi | Japan | ||
59 | Site Reference ID/Investigator# 39124 | Yamanashi | Japan |
Sponsors and Collaborators
- Mylan Inc.
- Taisho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Jun Kato, MD., Ph.D., Abbott Japan Co.,Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P10-765
Study Results
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. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Clarithromycin |
---|---|
Arm/Group Description | Those with an exposure |
Period Title: Overall Study | |
STARTED | 466 |
Analysis of Safety | 441 |
Analysis of NTM Lung Disease | 340 |
Analysis of Bacilli Negative Conversion | 285 |
Analysis of CGI | 249 |
COMPLETED | 101 |
NOT COMPLETED | 365 |
Baseline Characteristics
Arm/Group Title | Clarithromycin |
---|---|
Arm/Group Description | Those with an exposure |
Overall Participants | 340 |
Age, Customized (participants) [Number] | |
<45 years |
15
4.4%
|
45-64 years |
136
40%
|
65-74 years |
126
37.1%
|
>=75 years |
62
18.2%
|
unknown |
1
0.3%
|
Sex/Gender, Customized (participants) [Number] | |
Female |
256
75.3%
|
Male |
83
24.4%
|
unknown |
1
0.3%
|
Outcome Measures
Title | Bacilli Negative Conversion Rate |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis of the bacilli negative conversion |
Arm/Group Title | Clarithromycin |
---|---|
Arm/Group Description | Negative conversion / Yes |
Measure Participants | 285 |
Number [participants] |
269
79.1%
|
Title | Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale. |
Arm/Group Title | Clarithromycin |
---|---|
Arm/Group Description | Those with an exposure |
Measure Participants | 249 |
Effective |
217
|
Ineffective |
13
|
Deterioration |
10
|
Impossible to assess |
9
|
Title | Bacteriological Relapse Related to Duration of Clarithromycin Administration |
---|---|
Description | Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion |
Time Frame | 36 months |
Outcome Measure Data
Analysis Population Description |
---|
End of study (completers). Analysis of bacteriological relapse. |
Arm/Group Title | Clarithromycin |
---|---|
Arm/Group Description | The subjects who completed the study |
Measure Participants | 101 |
0-14 months CLR |
5
1.5%
|
≥15 months CLR |
0
0%
|
Adverse Events
Time Frame | During treatment with clarithromycin up to 3.4 years | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Clarithromycin | |
Arm/Group Description | Those with an exposure | |
All Cause Mortality |
||
Clarithromycin | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Clarithromycin | ||
Affected / at Risk (%) | # Events | |
Total | 35/441 (7.9%) | |
Blood and lymphatic system disorders | ||
Thrombocytopenia | 1/441 (0.2%) | 1 |
Cardiac disorders | ||
Arrhythmia | 1/441 (0.2%) | 1 |
Cardiac failure acute | 1/441 (0.2%) | 1 |
Ear and labyrinth disorders | ||
Vertigo positional | 1/441 (0.2%) | 1 |
Gastrointestinal disorders | ||
Dysphagia | 1/441 (0.2%) | 1 |
Large intestine polyp | 1/441 (0.2%) | 1 |
General disorders | ||
Pyrexia | 1/441 (0.2%) | 1 |
Immune system disorders | ||
Anti-neutrophil cytoplasmic antibody positive vasculitis | 1/441 (0.2%) | 1 |
Infections and infestations | ||
Bronchopulmonary aspergillosis | 1/441 (0.2%) | 1 |
Pneumonia | 3/441 (0.7%) | 3 |
Bacterial infection | 1/441 (0.2%) | 1 |
Pneumonia bacterial | 4/441 (0.9%) | 4 |
Atypical mycobacterial infection | 1/441 (0.2%) | 1 |
Investigations | ||
Weight decreased | 1/441 (0.2%) | 1 |
Metabolism and nutrition disorders | ||
Hyponatraemia | 1/441 (0.2%) | 1 |
Decreased appetite | 1/441 (0.2%) | 1 |
Dehydration | 1/441 (0.2%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
Bile duct cancer | 1/441 (0.2%) | 1 |
Colon cancer | 1/441 (0.2%) | 1 |
Lung neoplasm malignant | 1/441 (0.2%) | 1 |
Hepatocellular carcinoma | 2/441 (0.5%) | 2 |
Nervous system disorders | ||
Somnolence | 1/441 (0.2%) | 1 |
Loss of consciousness | 1/441 (0.2%) | 1 |
Optic neuritis | 1/441 (0.2%) | 1 |
Peripheral sensory neuropathy | 1/441 (0.2%) | 1 |
Subarachnoid haemorrhage | 1/441 (0.2%) | 1 |
Psychiatric disorders | ||
Disorientation | 1/441 (0.2%) | 1 |
Renal and urinary disorders | ||
Nephrotic syndrome | 1/441 (0.2%) | 1 |
Calculus urinary | 1/441 (0.2%) | 1 |
Haematuria | 1/441 (0.2%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Interstitial lung disease | 2/441 (0.5%) | 2 |
Alveoliltis allergic | 1/441 (0.2%) | 1 |
Haemoptysis | 2/441 (0.5%) | 2 |
Interstitial lung disease | 2/441 (0.5%) | 2 |
Pneumonia aspiration | 3/441 (0.7%) | 3 |
Pneumothorax | 1/441 (0.2%) | 1 |
Respiratory failure | 2/441 (0.5%) | 2 |
Skin and subcutaneous tissue disorders | ||
Drug eruption | 1/441 (0.2%) | 1 |
Erythema | 1/441 (0.2%) | 1 |
Urticaria | 1/441 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
Clarithromycin | ||
Affected / at Risk (%) | # Events | |
Total | 0/441 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The investigators will be granted by sponsor.
Results Point of Contact
Name/Title | Takao Miki, Medical Affairs |
---|---|
Organization | Mylan EPD Japan |
Phone | |
takao.miki@mylan.com |
- P10-765