Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Phase 3

Completed

• Conditions: Nontuberculous Mycobacterial Infections
• Interventions: Drug: Rifabutin

• 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.

Study Timeline

• Primary Completion: 2006-09
• Study First Submitted: 2008-01-14
• Status Verified: 2017-05
• Study Completion: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-23
• Last Update Posted: 2017-05-23

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

Group	Intervention	Description
Rifabutin	Rifabutin	Treatment 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

Name	Time	Method
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)	6 mos	neg cultures X3( sputum conversion)

Secondary Outcome Measures

Name	Time	Method
Microbiological Cultures	1year	neg cultures for 1 yr on treatment

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States