Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

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NCT00598962

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Study Location
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Mycobacterium Avium Complex
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

- Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination

- Available for long term followup

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


- History of macrolide or rifamycins allergy


- Laboratory evidence of mycobacterial resistance to azithromycin


- Children less than 18 years of age


- If a menstruating female, not pregnant and on adequate birth control


- HIV+ or at risk

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Mycobacterium Avium ComplexUse of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
NCT00598962
  1. Tyler, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
Official Title  ICMJE Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
Brief Summary To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)
Detailed Description Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC
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
Intervention  ICMJE
  • Drug: Azithromycin
    Dosage dependent on clinical factors such as age, weight and patient-specific health status
    Other Name: Zithromax
  • Drug: Rifabutin/rifampin
    Other Name: mycobutin/
Study Arms  ICMJE Experimental: azithromycin and rifabutin/rifampin
Azithromycin and rifabutin/rifampin administered three times weekly.
Interventions:
  • Drug: Azithromycin
  • Drug: Rifabutin/rifampin
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)		58
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2017
Actual Primary Completion Date November 2006   (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
  • Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
  • Available for long term followup

Exclusion Criteria:

  • History of macrolide or rifamycins allergy
  • Laboratory evidence of mycobacterial resistance to azithromycin
  • Children less than 18 years of age
  • If a menstruating female, not pregnant and on adequate birth control
  • HIV+ or at risk
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 NCT00598962
Other Study ID Numbers  ICMJE 426
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