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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03164291

Enrollment

170

Registered

2017-05-23

Start date

1984-06-30

Completion date

2017-05-18

Last updated

2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nontuberculous Mycobacterial Infections

Keywords

MAC and NTM

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.

Interventions

DRUGRifabutin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026