Mycobacterium Infections, AtypicalNCT01097005
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
An observational study of Mycobacterium Infections, Atypical, run by Mylan Inc. at 59 sites in Japan.
Trial summary
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Mycobacterium Infections, Atypical
- How many people
- 466 participants
- Where
- 59 sitesJapan
- Study dates
- Jan 2009to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Who may be able to join
- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Who cannot join
- 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)
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
Japan59 sites
Site Reference ID/Investigator# 36460
Aichi
Site Reference ID/Investigator# 39122
Aichi
Site Reference ID/Investigator# 36463
Akita
Site Reference ID/Investigator# 36470
Ehime
Site Reference ID/Investigator# 36471
Fukuoka
Site Reference ID/Investigator# 36472
Fukuoka
Site Reference ID/Investigator# 36473
Fukushima
Site Reference ID/Investigator# 36474
Gifu
Site Reference ID/Investigator# 36475
Hiroshima
Site Reference ID/Investigator# 36482
Hyōgo
Site Reference ID/Investigator# 36465
Inzai
Site Reference ID/Investigator# 36483
Ishikawa
Site Reference ID/Investigator# 36484
Kagoshima
Site Reference ID/Investigator# 36485
Kanagawa
Site Reference ID/Investigator# 36486
Kanagawa
Site Reference ID/Investigator# 36487
Kanagawa
Site Reference ID/Investigator# 54466
Kitakyushu
Site Reference ID/Investigator# 54468
Kobe
Site Reference ID/Investigator# 36488
Kochi
Site Reference ID/Investigator# 36513
Kofu
Site Reference ID/Investigator# 39126
Kumamoto
Site Reference ID/Investigator# 36489
Kyoto
Site Reference ID/Investigator# 36493
Kyoto
Site Reference ID/Investigator# 39123
Kyoto
Site Reference ID/Investigator# 54469
Maebashi
Site Reference ID/Investigator# 36494
Miyagi
Site Reference ID/Investigator# 36495
Miyazaki
Site Reference ID/Investigator# 36459
Nagoya
Site Reference ID/Investigator# 36461
Nagoya
Site Reference ID/Investigator# 54465
Nara
Site Reference ID/Investigator# 37145
Obihiro
Site Reference ID/Investigator# 36496
Ōita
Site Reference ID/Investigator# 36497
Okayama
Site Reference ID/Investigator# 39125
Okinawa
Site Reference ID/Investigator# 28404
Osaka
Site Reference ID/Investigator# 36492
Osaka
Site Reference ID/Investigator# 36501
Saitama
Site Reference ID/Investigator# 54464
Saitama
Site Reference ID/Investigator# 36477
Sapporo
Site Reference ID/Investigator# 36478
Sapporo
Site Reference ID/Investigator# 36481
Sapporo
Site Reference ID/Investigator# 36462
Seto
Site Reference ID/Investigator# 36503
Shimane
Site Reference ID/Investigator# 36506
Shimotsuke
Site Reference ID/Investigator# 36504
Shizuoka
Site Reference ID/Investigator# 36505
Shizuoka
Site Reference ID/Investigator# 36499
Takatsuki
Site Reference ID/Investigator# 15101
Tokyo
Site Reference ID/Investigator# 36507
Tokyo
Site Reference ID/Investigator# 36508
Tokyo
Site Reference ID/Investigator# 36509
Tokyo
Site Reference ID/Investigator# 36510
Tokyo
Site Reference ID/Investigator# 42710
Tokyo
Site Reference ID/Investigator# 54470
Tokyo
Site Reference ID/Investigator# 36458
Toyohashi
Site Reference ID/Investigator# 36511
Wakayama
Site Reference ID/Investigator# 37144
Wakayama
Site Reference ID/Investigator# 36512
Yamaguchi
Site Reference ID/Investigator# 39124
Yamanashi
About this study
To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.
Read the 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."
- Conditions
- Mycobacterium Infections, Atypical
- Keywords
- Mycobacterium Infections, Atypical
- Medical subject headings
- Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Klaricid | Those with an exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the treatment with clarithromycin, from 40 days to 1232 days
Secondary outcomes (2)
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")
Measured: 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mycobacterium Infections, AtypicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taisho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jun Kato, MD., Ph.D., Study director, Abbott Japan Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097005
- Sponsor's protocol ID
- P10-765
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2010
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Please contact the investigator, and discuss with us.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
- ClinicalTrials.gov ID
- NCT01097005
- Acronym / sponsor ID
- P10-765
- Conditions
- Mycobacterium Infections, Atypical
- Keywords
- Mycobacterium Infections, Atypical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Collaborators
- Taisho Pharmaceutical Co., Ltd.
- Study start
- Jan 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Posted 19 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Klaricid | – | –Those with an exposure |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Key inclusion criteria (1 listed)
- Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacilli Negative Conversion Rate
Time frame: 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
2 secondary outcomes
Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator
Time frame: When treatment with clarithromycin is discontinued, from 40 days to 1232 days
Bacteriological Relapse Related to Duration of Clarithromycin Administration
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Please contact the investigator, and discuss with us.
Related trials for Mycobacterium Infections, Atypical
RecruitingPhase 4
Hypertonic Saline for MAC
Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
RecruitingPhase 1
IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)
Nontuberculous Mycobacterium Infection
Enrolling by invitationObservational study
Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Lung Disease
RecruitingObservational study
Controls for Respiratory Diseases
Chronic Obstructive Pulmonary Disease, Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Kato, MD., Ph.D. study director
Abbott Japan Co.,Ltd
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Infections, Atypical, run by Mylan Inc. at 59 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacilli Negative Conversion Rate (time frame: During the treatment with clarithromycin, from 40 days to 1232 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.