The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance

NCT07514364 | Recruiting Phase 4

• 1 other identifier: 202411007MINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mycobacterium Abscessus Lung Disease

Outcome Measures

Primary Outcomes (1)

• In the study period, we have screened 286 patients with kidney transplant and enrolled 50 participants who were KTR and had LTBI.

  In the study period, we have screened 286 patients with kidney transplant and enrolled 50 participants who were KTR and had LTBI. Among them, 24 received 9H regimen, 10 had 3HR, one underwent 3HP, one used 4R, and the remaining 14 declined LTBI treatment. Finally, there were 36 patients received LTBI treatment. Regarding ADRs, there was no severe ADR, but 3 of 3HR group had mild (Grade 1) non-specific reaction of malaise, which was borderline higher than 9H group (25% vs 0%, p=0.025). The effect on FK506 by rifamycin was all adjustable except one using 3HP regimen. There was no kidney injury found. The dosage of FK506 needed to titrated up to around two-fold. Only one of 9H group had interrupted LTBI treatment course due to other cause. The incompletion rate was insignificant difference between 9H and 3HR groups (4% vs 0%, p=667). 3HR regimen cost less and patients had lower clinic return times compared with 9H group.

  2years

Study Arms (2)

Treatment Group

EXPERIMENTAL

Standard Rifabutin dose group: Oral administration once daily, with dosage adjusted based on the patient's body weight and hepatic/renal function; typically 300 mg, combined with standard therapy.

Drug: Rifabutin

Control Group

EXPERIMENTAL

Standard therapy: Amikacin, Imipenem, Tigecycline, Linezolid, and Clarithromycin or Azithromycin.

Drug: No Rifabutin

Interventions

No Rifabutin DRUG

the control group (received standard treatment only).

Control Group

Rifabutin DRUG

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

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Rifabutin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 7, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: June 18, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-01

Locations

TW (1)