Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Nontuberculous Mycobacterial Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164291
• Other study ID #: 072
• Status: Completed
• Phase: Phase 3
• First received: January 14, 2008
• Last updated: May 19, 2017
• Start date: June 1984
• Est. completion date: May 18, 2017

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center at Tyler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: May 18, 2017
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections
• Nontuberculous Mycobacterial Infections

Intervention

Drug:
• Rifabutin
Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at Tyler	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)	neg cultures X3( sputum conversion)	6 mos
Secondary	Microbiological Cultures	neg cultures for 1 yr on treatment	1year