Rifabutin for Mycobacterium abscessus lung infection with inducible clarithromycin resistance
Official title: The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study
Run by National Taiwan University Hospital · NCT07514364 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | March 1, 2026 |
| Study ends | June 18, 2026 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07514364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients without inducible clarithromycin resistance, pregnant or breastfeeding individuals, and those with known rifabutin hypersensitivity are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Existing evidence is limited to in vitro studies and case reports, and there have been no prior systematic clinical trials showing efficacy.
Who can join: the full rules
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 it's running
-
National Taiwan University Hospital
Taipei, Taiwan Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.