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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 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:
NCT00598962
First received: January 11, 2008
Last updated: NA
Last verified: November 2007
History: No changes posted

January 11, 2008
January 11, 2008
December 1994
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Use of Azithromycin and Rifabutin Administered Three Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
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

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycobacterium Avium Complex
Drug: Azithromycin, Rifabutin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Other Names:
  • Zithromax
  • Mycobutin
1
Intervention: Drug: Azithromycin, Rifabutin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
58
Not Provided
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00598962
426
No
Richard J. Wallace Jr., M.D., The University of Texas Health Science Center at Tyler
The University of Texas Health Science Center at Tyler
Pfizer
Principal Investigator: Richard J Wallace Jr., M.D. The University of Texas Health Science Center at Tyler
The University of Texas Health Science Center at Tyler
November 2007

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