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CompletedNCT00600769Updated May 23, 2017

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

A Phase 4 interventional study of Clarithromycin in Nontuberculous Mycobacteria and Mycobacterium Avium Complex, sponsored by The University of Texas Health Science Center at Tyler. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by The University of Texas Health Science Center at Tyler · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 17 years after the study started (first participant enrolled Jan 1991, registered Jan 2008).
Phase
Phase 4
Study type
Interventional
Enrollment
210
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Read the detailed description

Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

02

Conditions studied

  • Nontuberculous Mycobacteria
  • Mycobacterium Avium Complex

Keywords

  • MAC
  • NTM
03

In context

Mycobacterium Infections

136 studies on the registry are indexed under Mycobacterium Infections; 17 are open to participants now.

This study's enrollment of 210 is above the median of 88 across 68 interventional studies indexed under Mycobacterium Infections.

Browse Mycobacterium Infections studies →

Lead sponsor

The University of Texas Health Science Center at Tyler is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
210 participants (actual)

Study arms

  • Other
    treatment of MAC and other NTM

    Clarithromycin drug given twice daily.

    Drug: Clarithromycin

Interventions

  • DrugClarithromycin

    Dosage dependent on clinical factors such as age, weight and patient-specific health status

    Also known as: Biaxin

06

What researchers measure

Primary outcomes

  1. Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures

    neg culture x3( sputum conversion)

    Time frame: 6 months

Secondary outcomes

  1. Microbiological cultures

    neg culture for 1 yr on treatment

    Time frame: 1yr

07

Study locations

1 site
  • The University of Texas Health Science Center at Tyler
    Tyler, Texas 75708, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00600769
Lead sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Abbott
Responsible party
Richard J. Wallace, Jr., M.D. (Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler) — Principal investigator
First posted
Jan 25, 2008
Start date
Jan 1991
Primary completion
Nov 2006
Completion
May 18, 2017
Last update
May 23, 2017

Study contacts

Richard J Wallace, MD
principal investigator · UTHSCT

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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