NCT01097005

Brief Summary

To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

59 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 19, 2016

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2015

Enrollment Period

5.2 years

First QC Date

February 26, 2010

Results QC Date

June 17, 2015

Last Update Submit

March 18, 2022

Conditions

Mycobacterium Infections, Atypical

Keywords

Mycobacterium Infections, Atypical

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

  • Bacteriological Relapse Related to Duration of Clarithromycin Administration

    36 months

Study Arms (1)

Klaricid

Those with an exposure

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid

You may qualify if:

  • Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (59)

Site Reference ID/Investigator# 36460

Aichi, Japan

Location

Site Reference ID/Investigator# 39122

Aichi, Japan

Location

Site Reference ID/Investigator# 36463

Akita, Japan

Location

Site Reference ID/Investigator# 36470

Ehime, Japan

Location

Site Reference ID/Investigator# 36471

Fukuoka, Japan

Location

Site Reference ID/Investigator# 36472

Fukuoka, Japan

Location

Site Reference ID/Investigator# 36473

Fukushima, Japan

Location

Site Reference ID/Investigator# 36474

Gifu, Japan

Location

Site Reference ID/Investigator# 36475

Hiroshima, Japan

Location

Site Reference ID/Investigator# 36482

Hyōgo, Japan

Location

Site Reference ID/Investigator# 36465

Inzai, Japan

Location

Site Reference ID/Investigator# 36483

Ishikawa, Japan

Location

Site Reference ID/Investigator# 36484

Kagoshima, Japan

Location

Site Reference ID/Investigator# 36485

Kanagawa, Japan

Location

Site Reference ID/Investigator# 36486

Kanagawa, Japan

Location

Site Reference ID/Investigator# 36487

Kanagawa, Japan

Location

Site Reference ID/Investigator# 54466

Kitakyushu, Japan

Location

Site Reference ID/Investigator# 54468

Kobe, Japan

Location

Site Reference ID/Investigator# 36488

Kochi, Japan

Location

Site Reference ID/Investigator# 36513

Kofu, Japan

Location

Site Reference ID/Investigator# 39126

Kumamoto, Japan

Location

Site Reference ID/Investigator# 36489

Kyoto, Japan

Location

Site Reference ID/Investigator# 36493

Kyoto, Japan

Location

Site Reference ID/Investigator# 39123

Kyoto, Japan

Location

Site Reference ID/Investigator# 54469

Maebashi, Japan

Location

Site Reference ID/Investigator# 36494

Miyagi, Japan

Location

Site Reference ID/Investigator# 36495

Miyazaki, Japan

Location

Site Reference ID/Investigator# 36459

Nagoya, Japan

Location

Site Reference ID/Investigator# 36461

Nagoya, Japan

Location

Site Reference ID/Investigator# 54465

Nara, Japan

Location

Site Reference ID/Investigator# 37145

Obihiro, Japan

Location

Site Reference ID/Investigator# 36497

Okayama, Japan

Location

Site Reference ID/Investigator# 39125

Okinawa, Japan

Location

Site Reference ID/Investigator# 28404

Osaka, Japan

Location

Site Reference ID/Investigator# 36492

Osaka, Japan

Location

Site Reference ID/Investigator# 36496

Ōita, Japan

Location

Site Reference ID/Investigator# 36501

Saitama, Japan

Location

Site Reference ID/Investigator# 54464

Saitama, Japan

Location

Site Reference ID/Investigator# 36477

Sapporo, Japan

Location

Site Reference ID/Investigator# 36478

Sapporo, Japan

Location

Site Reference ID/Investigator# 36481

Sapporo, Japan

Location

Site Reference ID/Investigator# 36462

Seto, Japan

Location

Site Reference ID/Investigator# 36503

Shimane, Japan

Location

Site Reference ID/Investigator# 36506

Shimotsuke, Japan

Location

Site Reference ID/Investigator# 36504

Shizuoka, Japan

Location

Site Reference ID/Investigator# 36505

Shizuoka, Japan

Location

Site Reference ID/Investigator# 36499

Takatsuki, Japan

Location

Site Reference ID/Investigator# 15101

Tokyo, Japan

Location

Site Reference ID/Investigator# 36507

Tokyo, Japan

Location

Site Reference ID/Investigator# 36508

Tokyo, Japan

Location

Site Reference ID/Investigator# 36509

Tokyo, Japan

Location

Site Reference ID/Investigator# 36510

Tokyo, Japan

Location

Site Reference ID/Investigator# 42710

Tokyo, Japan

Location

Site Reference ID/Investigator# 54470

Tokyo, Japan

Location

Site Reference ID/Investigator# 36458

Toyohashi, Japan

Location

Site Reference ID/Investigator# 36511

Wakayama, Japan

Location

Site Reference ID/Investigator# 37144

Wakayama, Japan

Location

Site Reference ID/Investigator# 36512

Yamaguchi, Japan

Location

Site Reference ID/Investigator# 39124

Yamanashi, Japan

Location

MeSH Terms

Conditions

Mycobacterium Infections, Nontuberculous

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Takao Miki, Medical Affairs
Organization
Mylan EPD Japan
takao.miki@mylan.com

Study Officials

  • Jun Kato, MD., Ph.D.

    Abbott Japan Co.,Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

April 1, 2010

Study Start

January 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 31, 2022

Results First Posted

September 19, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will share

Please contact the investigator, and discuss with us.

Locations

JP(59)