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

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ClinicalTrials.gov Identifier: NCT01097005
Recruitment Status : Completed
First Posted : April 1, 2010
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Collaborator:
Taisho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Mylan Inc.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Mycobacterium Infections, Atypical
Enrollment 466
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 Details  
Arm/Group Title Clarithromycin
Hide Arm/Group Description Those with an exposure
Period Title: Overall Study
Started 466 [1]
Analysis of Safety 441 [2]
Analysis of NTM Lung Disease 340 [3]
Analysis of Bacilli Negative Conversion 285 [4]
Analysis of CGI 249 [5]
Completed 101
Not Completed 365
Reason Not Completed
Case Report Form not collected             18
Subjects cannot visit the hospital             1
Poor medication compliance             1
No examination data available             244
Deviation from exclusion criteria             37
Adverse Event             14
Discontinuance by complication             50
[1]
number of participants who were enrolled for this study.
[2]
number of participants who could be measured for Adverse Events
[3]
number of participants who contributed to the Baseline data
[4]
number of participants who were analysed for bacilli negative conversion
[5]
number of participants who were measured for Clinical Global Improvement (CGI)
Arm/Group Title Clarithromycin
Hide Arm/Group Description Those with an exposure
Overall Number of Baseline Participants 340
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants
<45 years 15
45-64 years 136
65-74 years 126
>=75 years 62
unknown 1
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 340 participants
Female 256
Male 83
unknown 1
1.Primary Outcome
Title Bacilli Negative Conversion Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of the bacilli negative conversion
Arm/Group Title Clarithromycin
Hide Arm/Group Description:
Negative conversion / Yes
Overall Number of Participants Analyzed 285
Measure Type: Number
Unit of Measure: participants
269
2.Secondary Outcome
Title Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.
Arm/Group Title Clarithromycin
Hide Arm/Group Description:
Those with an exposure
Overall Number of Participants Analyzed 249
Measure Type: Number
Unit of Measure: Number of patients
Effective 217
Ineffective 13
Deterioration 10
Impossible to assess 9
3.Secondary Outcome
Title Bacteriological Relapse Related to Duration of Clarithromycin Administration
Hide Description Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
End of study (completers). Analysis of bacteriological relapse.
Arm/Group Title Clarithromycin
Hide Arm/Group Description:
The subjects who completed the study
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: participants
0-14 months CLR 5
≥15 months CLR 0
Time Frame During treatment with clarithromycin up to 3.4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clarithromycin
Hide Arm/Group Description Those with an exposure
All-Cause Mortality
Clarithromycin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clarithromycin
Affected / at Risk (%) # Events
Total   35/441 (7.94%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1 [1]  1/441 (0.23%)  1
Cardiac disorders   
Arrhythmia  1 [2]  1/441 (0.23%)  1
Cardiac failure acute  1 [2]  1/441 (0.23%)  1
Ear and labyrinth disorders   
Vertigo positional  1 [2]  1/441 (0.23%)  1
Gastrointestinal disorders   
Dysphagia  1 [2]  1/441 (0.23%)  1
Large intestine polyp  1 [2]  1/441 (0.23%)  1
General disorders   
Pyrexia  1 [2]  1/441 (0.23%)  1
Immune system disorders   
Anti-neutrophil cytoplasmic antibody positive vasculitis  1 [2]  1/441 (0.23%)  1
Infections and infestations   
Bronchopulmonary aspergillosis  1 [2]  1/441 (0.23%)  1
Pneumonia  1 [2]  3/441 (0.68%)  3
Bacterial infection  1 [2]  1/441 (0.23%)  1
Pneumonia bacterial  1 [2]  4/441 (0.91%)  4
Atypical mycobacterial infection  1 [2]  1/441 (0.23%)  1
Investigations   
Weight decreased  1 [1]  1/441 (0.23%)  1
Metabolism and nutrition disorders   
Hyponatraemia  1 [1]  1/441 (0.23%)  1
Decreased appetite  1 [1]  1/441 (0.23%)  1
Dehydration  1 [2]  1/441 (0.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bile duct cancer  1 [1]  1/441 (0.23%)  1
Colon cancer  1 [1]  1/441 (0.23%)  1
Lung neoplasm malignant  1 [2]  1/441 (0.23%)  1
Hepatocellular carcinoma  1 [2]  2/441 (0.45%)  2
Nervous system disorders   
Somnolence  1 [1]  1/441 (0.23%)  1
Loss of consciousness  1 [2]  1/441 (0.23%)  1
Optic neuritis  1 [2]  1/441 (0.23%)  1
Peripheral sensory neuropathy  1 [2]  1/441 (0.23%)  1
Subarachnoid haemorrhage  1 [2]  1/441 (0.23%)  1
Psychiatric disorders   
Disorientation  1 [1]  1/441 (0.23%)  1
Renal and urinary disorders   
Nephrotic syndrome  1 [1]  1/441 (0.23%)  1
Calculus urinary  1 [2]  1/441 (0.23%)  1
Haematuria  1 [2]  1/441 (0.23%)  1
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease  1 [1]  2/441 (0.45%)  2
Alveoliltis allergic  1 [2]  1/441 (0.23%)  1
Haemoptysis  1 [2]  2/441 (0.45%)  2
Interstitial lung disease  1 [2]  2/441 (0.45%)  2
Pneumonia aspiration  1 [2]  3/441 (0.68%)  3
Pneumothorax  1 [2]  1/441 (0.23%)  1
Respiratory failure  1 [2]  2/441 (0.45%)  2
Skin and subcutaneous tissue disorders   
Drug eruption  1 [1]  1/441 (0.23%)  1
Erythema  1 [1]  1/441 (0.23%)  1
Urticaria  1 [2]  1/441 (0.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
[1]
Causal relationship with the study drug was rated as "possible" by the investigator.
[2]
Causal relationship with the study drug was rated as "Not related" by the investigator.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clarithromycin
Affected / at Risk (%) # Events
Total   0/441 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigators will be granted by sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Takao Miki, Medical Affairs
Organization: Mylan EPD Japan
EMail: takao.miki@mylan.com
Layout table for additonal information
Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01097005     History of Changes
Other Study ID Numbers: P10-765
First Submitted: February 26, 2010
First Posted: April 1, 2010
Results First Submitted: June 17, 2015
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016