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RECRUITING
NCT07514364
PHASE4

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Background: Mycobacterium abscessus, one of the most common species of nontuberculous mycobacterium (NTM), poses a significant clinical challenge due to its natural resistance to antibiotics and high treatment failure rates, particularly in lung diseases. Among its subspecies, M. abscessus subspecies abscessus is especially prone to developing inducible resistance to Clarithromycin. This resistance mechanism is primarily due to the activation of the erm(41) gene,which inhibits Clarithromycin from effectively binding to the bacterial ribosome, diminishing its bactericidal efficacy. Rifabutin, an antibiotic widely used in treating tuberculosis and certain NTM infections, has been shown to inhibit the activation of the erm(41) gene by suppressing the whiB7 protein in M. abscessus, suggesting potential efficacy against inducible resistance. However,current evidence primarily stems from in vitro susceptibility studies and case reports, with a notable lack of systematic clinical trials.

Official title: The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-01-01

Completion Date

2026-06-18

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

DRUG

Rifabutin

The treatment group (received standard treatment plus Rifabutin, with the dosage adjusted according to weight and renal function)

DRUG

No Rifabutin

the control group (received standard treatment only).

Locations (1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin County, Taiwan