CompletedNCT00598962Updated May 23, 2017

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

A Phase 4 interventional study of Azithromycin and Rifabutin/rifampin in Mycobacterium Avium Complex, sponsored by The University of Texas Health Science Center at Tyler. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-23.

Sponsored by The University of Texas Health Science Center at Tyler · Phase 4, Interventional, and Treatment

From the registry’s dates

Registered 13 years 1 month after the study started (first participant enrolled Dec 1994, registered Jan 2008).

Phase: Phase 4
Study type: Interventional
Enrollment: 58
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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)

Read the detailed description

Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Conditions studied

Mycobacterium Avium Complex

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Keywords

In context

Mycobacterium avium-intracellulare Infection

72 studies on the registry are indexed under Mycobacterium avium-intracellulare Infection; 8 are open to participants now.

This study's enrollment of 58 is below the median of 90 across 46 interventional studies indexed under Mycobacterium avium-intracellulare Infection.

Browse Mycobacterium avium-intracellulare Infection studies →

Lead sponsor

The University of Texas Health Science Center at Tyler is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
azithromycin and rifabutin/rifampin
Azithromycin and rifabutin/rifampin administered three times weekly.
Drug: Azithromycin · Drug: Rifabutin/rifampin

Interventions

DrugAzithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Also known as: Zithromax
DrugRifabutin/rifampin
Also known as: mycobutin/

What researchers measure

Primary outcomes

Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
neg cultures X3 ( sputum conversion)
Time frame: 6 months

Secondary outcomes

Microbiological cultures
neg culture 1 yr on treatment
Time frame: 1yr

Study locations

1 site

The University of Texas Health Science Center at Tyler
Tyler, Texas 75708, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00598962
Lead sponsor: The University of Texas Health Science Center at Tyler
Collaborators: Pfizer
Responsible party: Richard J. Wallace, Jr., M.D. (Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler) — Principal investigator
First posted: Jan 23, 2008
Start date: Dec 1994
Primary completion: Nov 2006
Completion: May 18, 2017
Last update: May 23, 2017

Study contacts

Richard J Wallace Jr., M.D.

principal investigator · The University of Texas Health Science Center at Tyler

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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