RecruitingPhase 4NCT07514364

The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

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


Sponsor

National Taiwan University Hospital

Enrollment

60 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Adults aged ≥ 18 years
  • Diagnosis of pulmonary disease caused by Mycobacterium abscessus confirmed by clinical evaluation and laboratory results
  • Antimicrobial susceptibility testing indicating inducible resistance to clarithromycin
  • Clinically stable and suitable for antibiotic treatment
  • Radiographic evidence of active pulmonary infection
  • Willing and able to provide informed consent

Exclusion Criteria2

  • Known hypersensitivity to rifabutin or intolerance to other study medications
  • Pregnant or breastfeeding women

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Interventions

DRUGRifabutin

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

DRUGNo Rifabutin

the control group (received standard treatment only).


Locations(1)

National Taiwan University Hospital Yunlin Branch

Douliu, Yunlin County, Taiwan

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NCT07514364