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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-01-31

Study Completion Date

2017-05-18

Brief Summary

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

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Detailed Description

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

Conditions

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Nontuberculous Mycobacteria Mycobacterium Avium Complex

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment of MAC and other NTM

Clarithromycin drug given twice daily.

Group Type OTHER

Clarithromycin

Intervention Type DRUG

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

Interventions

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Clarithromycin

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

Intervention Type DRUG

Other Intervention Names

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Biaxin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No