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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Phase 4

Conditions

Nontuberculous Mycobacteria
Mycobacterium Avium Complex

Treatments

Drug: Clarithromycin

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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

Full description

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

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

210 participants in 1 patient group

treatment of MAC and other NTM
Other group
Description:
Clarithromycin drug given twice daily.
Treatment:
Drug: Clarithromycin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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