NCT00600769

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 1991

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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, 1991

Completed
15.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

15.8 years

First QC Date

January 14, 2008

Last Update Submit

May 19, 2017

Conditions

Nontuberculous MycobacteriaMycobacterium Avium Complex

Keywords

MACNTM

Outcome Measures

Primary Outcomes (1)

  • Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures

    neg culture x3( sputum conversion)

    6 months

Secondary Outcomes (1)

  • Microbiological cultures

    1yr

Study Arms (1)

treatment of MAC and other NTM

OTHER

Clarithromycin drug given twice daily.

Drug: Clarithromycin

Interventions

ClarithromycinDRUG

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

Also known as: Biaxin
treatment of MAC and other NTM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection

Interventions

Clarithromycin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Richard J Wallace, MD

    UTHSCT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Department of Microbiology

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

January 1, 1991

Primary Completion

November 1, 2006

Study Completion

May 18, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)