Azithromycin in the Treatment of M. Avium Complex Lung Disease

NCT00599079

Last updated date
Study Location
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium Complex Lung Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Mycobacterium Avium Complex Lung DiseaseAzithromycin in the Treatment of M. Avium Complex Lung Disease
NCT00599079
  1. Tyler, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Azithromycin in the Treatment of M. Avium Complex Lung Disease
Official Title  ICMJE Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease
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.
Detailed Description To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mycobacterium Avium Complex Lung Disease
Intervention  ICMJE Drug: Azithromycin
Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
Other Name: Zithromax
Study Arms  ICMJE Experimental: Azithromycin
Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease
Intervention: Drug: Azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2008)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2017
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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; 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599079
Other Study ID Numbers  ICMJE 340
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler
Study Sponsor  ICMJE The University of Texas Health Science Center at Tyler
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Richard J Wallace Jr., M.D.The University of Texas Health Science Center at Tyler
PRS Account The University of Texas Health Science Center at Tyler
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP