Rifabutin for Mycobacterium abscessus lung infection with inducible clarithromycin resistance
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study
This trial will test whether adding rifabutin to standard antibiotics helps adults with Mycobacterium abscessus lung disease that shows inducible clarithromycin resistance.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Douliu, Yunlin County) |
| Trial ID | NCT07514364 on ClinicalTrials.gov |
What this trial studies
Adults with culture-confirmed Mycobacterium abscessus pulmonary disease and laboratory-proven inducible clarithromycin resistance will be enrolled and receive standard antibiotic therapy with or without adjunctive rifabutin. The trial will measure microbiological outcomes including sputum culture conversion, clinical status, progression-free survival, and treatment-related adverse events. Outcomes in the rifabutin and no-rifabutin groups will be compared over a defined follow-up period to determine whether rifabutin improves response or delays progression. Safety and tolerability will be monitored throughout treatment.
Who should consider this trial
Good fit: Adults (≥18) with radiographic and laboratory-confirmed Mycobacterium abscessus lung infection demonstrating inducible clarithromycin resistance who are clinically stable and able to provide informed consent.
Not a fit: Patients without inducible clarithromycin resistance, pregnant or breastfeeding individuals, and those with known rifabutin hypersensitivity are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding rifabutin could overcome inducible clarithromycin resistance and increase sputum culture conversion and clinical improvement.
How similar studies have performed: Existing evidence is limited to in vitro studies and case reports, and there have been no prior systematic clinical trials showing efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Known hypersensitivity to rifabutin or intolerance to other study medications * Pregnant or breastfeeding women
Where this trial is running
Douliu, Yunlin County
- National Taiwan University Hospital Yunlin Branch — Douliu, Yunlin County, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.