Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium

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.

Study Overview

• Status: Completed
• Conditions: Nontuberculous Mycobacterial Infections
• Intervention / Treatment: Drug: Rifabutin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Rifabutin; Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status; Other Names: mycobutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)	neg cultures X3( sputum conversion)	6 mos

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological Cultures	neg cultures for 1 yr on treatment	1year

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at Tyler
• Collaborators: Pfizer
• Investigators: Principal Investigator: Richard J Wallace, Jr, M.D., The University of Texas Health Center at Tyler; Study Chair: William B Girard, MD, University of Texas Health Science Center IRB Chair

Study record dates

Study Major Dates

• Study Start: June 1, 1984
• Primary Completion (Actual): September 1, 2006
• Study Completion (Actual): May 18, 2017

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: MAC and NTM
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections, Nontuberculous; Infections; Mycobacterium Infections; Mycobacterium avium-intracellulare Infection; Anti-Infective Agents; Anti-Bacterial Agents; Antitubercular Agents; Antibiotics, Antitubercular; Rifabutin
• Other Study ID Numbers: 072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No