Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Nontuberculous Mycobacterial Infections

Treatments: Drug: Rifabutin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03164291

072

Details and patient eligibility

About

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.

Full description

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

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

170 participants in 1 patient group

Rifabutin

Experimental group

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)

Treatment:

Drug: Rifabutin