drugset / Trial / NCT07514364

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

NCT07514364

Phase 4 Recruiting 60 enrolled National Taiwan University Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-01
Primary completion
2026-03-01
Completion
2026-06-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifabutin Small molecule 300 mg Oral