NCT07514364

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Specific Aims: The primary aim of this study is to evaluate the efficacy and safety of Rifabutin in treating M. abscessus lung disease with inducible Clarithromycin resistance. Specific objectives include: * Assessing sputum culture conversion rates and clinical improvement when Rifabutin is added to the standard treatment regimen. * Investigating the effect of Rifabutin on progression-free survival (PFS). * Evaluating patient tolerance and adverse events throughout treatment.

Conditions

• Mycobacterium Abscessus Lung Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-03-01
• Completion: 2026-06-18
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Taiwan