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Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

Primary Purpose

Nontuberculous Mycobacteria, Mycobacterium Avium Complex

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clarithromycin
Sponsored by
The University of Texas Health Science Center at Tyler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nontuberculous Mycobacteria focused on measuring MAC, NTM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential lung pathogens (except for the coexistence of M. abscessus)
  • Age 18 years and older

Exclusion Criteria:

  • History of macrolide allergy
  • Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin
  • Children less than 18 years of age
  • If a menstruating female, not pregnant and on adequate birth control

Sites / Locations

  • The University of Texas Health Science Center at Tyler

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment of MAC and other NTM

Arm Description

Clarithromycin drug given twice daily.

Outcomes

Primary Outcome Measures

Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
neg culture x3( sputum conversion)

Secondary Outcome Measures

Microbiological cultures
neg culture for 1 yr on treatment

Full Information

First Posted
January 14, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00600769
Brief Title
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Official Title
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1991 (Actual)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
Detailed Description
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nontuberculous Mycobacteria, Mycobacterium Avium Complex
Keywords
MAC, NTM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment of MAC and other NTM
Arm Type
Other
Arm Description
Clarithromycin drug given twice daily.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Other Intervention Name(s)
Biaxin
Intervention Description
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
Description
neg culture x3( sputum conversion)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiological cultures
Description
neg culture for 1 yr on treatment
Time Frame
1yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential lung pathogens (except for the coexistence of M. abscessus) Age 18 years and older Exclusion Criteria: History of macrolide allergy Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin Children less than 18 years of age If a menstruating female, not pregnant and on adequate birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace, MD
Organizational Affiliation
UTHSCT
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

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