The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rifabutin, No Rifabutin.
- Who it may be relevant to
- Registry conditions: Mycobacterium Abscessus Lung Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study
Overview
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.
Interventions
- 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).
Primary outcome measures
- In the study period, we have screened 286 patients with kidney transplant and enrolled 50 participants who were KTR and had LTBI. [Time frame: 2years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT07514364 · 202411007MINA