The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Known hypersensitivity to rifabutin or intolerance to other study medications

Pregnant or breastfeeding women

Trial design

Treatments tested in this trial

  • Rifabutin
  • No Rifabutin

Treatment groups

60 Participants
are divided into 2 treatment groups