NCT00599079

Brief Summary

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 1993

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1993

Completed
15 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
9.1 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

15.3 years

First QC Date

January 11, 2008

Last Update Submit

May 19, 2017

Conditions

Mycobacterium Avium Complex Lung Disease

Keywords

MAC

Outcome Measures

Primary Outcomes (1)

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

    neg cultures X3( sputum conversion)

    6 months

Secondary Outcomes (1)

  • Microbiological cultures

    1yr

Study Arms (1)

Azithromycin

EXPERIMENTAL

Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease

Drug: Azithromycin

Interventions

AzithromycinDRUG

Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors

Also known as: Zithromax
Azithromycin

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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).
  • Age 18 and older
  • Pretreatment isolate of M. avium complex available for MIC determination

You may not qualify if:

  • History of macrolide allergy
  • Received macrolide therapy in last two months
  • 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

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Richard J Wallace Jr., M.D.

    The University of Texas Health Science Center at Tyler

    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 11, 2008

First Posted

January 23, 2008

Study Start

February 1, 1993

Primary Completion

May 1, 2008

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)