search
Back to results

Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Primary Purpose

Nontuberculous Mycobacterial Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rifabutin
Sponsored by
The University of Texas Health Science Center at Tyler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nontuberculous Mycobacterial Infections focused on measuring MAC and NTM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Tyler

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rifabutin

Arm Description

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)

Outcomes

Primary Outcome Measures

Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
neg cultures X3( sputum conversion)

Secondary Outcome Measures

Microbiological Cultures
neg cultures for 1 yr on treatment

Full Information

First Posted
January 14, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT03164291
Brief Title
Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 1984 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
May 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nontuberculous Mycobacterial Infections
Keywords
MAC and NTM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifabutin
Arm Type
Experimental
Arm Description
Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Other Intervention Name(s)
mycobutin
Intervention Description
Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
Description
neg cultures X3( sputum conversion)
Time Frame
6 mos
Secondary Outcome Measure Information:
Title
Microbiological Cultures
Description
neg cultures for 1 yr on treatment
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace, Jr, M.D.
Organizational Affiliation
The University of Texas Health Center at Tyler
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William B Girard, MD
Organizational Affiliation
University of Texas Health Science Center IRB Chair
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

We'll reach out to this number within 24 hrs