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

This study is ongoing, but not recruiting participants.

First Received: January 11, 2008 No Changes Posted

Sponsor:	The University of Texas Health Science Center at Tyler
Collaborator:	Pfizer
Information provided by:	The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:	NCT00598962

Purpose

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

Condition	Intervention	Phase
Mycobacterium Avium Complex	Drug: Azithromycin, Rifabutin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Mycobacterial Infections

Drug Information available for: Rifabutin Azithromycin

U.S. FDA Resources

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:	58
Study Start Date:	December 1994
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Azithromycin, Rifabutin Dosage dependent on clinical factors such as age, weight and patient-specific health status

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598962

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:	The University of Texas Health Science Center at Tyler ( Richard J. Wallace Jr., M.D. )
Study ID Numbers:	426
Study First Received:	January 11, 2008
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00598962 History of Changes
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:

Bacterial Infections
Anti-Infective Agents
Rifabutin
Pharmacologic Actions
Actinomycetales Infections
Mycobacterium Infections, Atypical
Antibiotics, Antitubercular
Mycobacterium avium-intracellulare Infection

Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Lung Diseases
Azithromycin
Therapeutic Uses
Mycobacterium Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on February 04, 2010