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Azithromycin in the Treatment of M. Avium Complex Lung Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The University of Texas Health Science Center at Tyler.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT00599079
First received: January 11, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Mycobacterium Avium Complex
M. Abscessus
Drug: Azithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at Tyler:

Primary Outcome Measures:
  • Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at three months, then at six months, then annually and prn for life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Microbiological cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at three months, then at six months, then annually and prn for life ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: February 1993
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Azithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Other Name: Zithromax

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599079

Locations
United States, Texas
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
Sponsors and Collaborators
The University of Texas Health Science Center at Tyler
Pfizer
Investigators
Principal Investigator: Richard J Wallace Jr., M.D. The University of Texas Health Science Center at Tyler
  More Information

No publications provided

Responsible Party: Richard J. Wallace Jr., M.D., The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier: NCT00599079     History of Changes
Other Study ID Numbers: 340
Study First Received: January 11, 2008
Last Updated: January 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at Tyler:
MAC

Additional relevant MeSH terms:
Lung Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014