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Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Phase 3
Completed
Conditions
Nontuberculous Mycobacterial Infections
Interventions
Registration Number
NCT03164291
Lead Sponsor
The University of Texas Health Science Center at Tyler
Brief Summary

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin.

Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Detailed Description

Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
170
Inclusion Criteria
  • Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria
Exclusion Criteria
  • Children less than 18 years of age
  • Pregnancy
  • Low platelet count, except with very serious disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RifabutinRifabutinTreatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)
Primary Outcome Measures
NameTimeMethod
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)6 mos

neg cultures X3( sputum conversion)

Secondary Outcome Measures
NameTimeMethod
Microbiological Cultures1year

neg cultures for 1 yr on treatment

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler

🇺🇸

Tyler, Texas, United States

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