Mycobacterium Abscessus Lung DiseasePhase 4NCT07514364
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance
A Phase 4 study testing Rifabutin and No Rifabutin in people with Mycobacterium Abscessus Lung Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Abscessus Lung Disease
- What is being tested?
- Rifabutin and No Rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 18 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known hypersensitivity to rifabutin or intolerance to other study medications
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chin-Chung Shu, 0223123456, ccshu@ntu.edu.tw
About this study
Official title: The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study
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.
Read the 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
- Being tested
- Rifabutin, No Rifabutin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifabutinDrug
The treatment group (received standard treatment plus Rifabutin, with the dosage adjusted according to weight and renal function)
No RifabutinDrug
the control group (received standard treatment only).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rifabutin |
| Control Group | Experimental | Standard therapy: Amikacin, Imipenem, Tigecycline, Linezolid, and Clarithromycin or Azithromycin. Receives: Drug: No Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Mar 2026
- Study completion18 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Abscessus Lung DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514364
- Sponsor's protocol ID
- 202411007MINA
- Status last verified
- Jan 2026
- First submitted
- 20 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance: a Randomized Study
- ClinicalTrials.gov ID
- NCT07514364
- Acronym / sponsor ID
- 202411007MINA
- Conditions
- Mycobacterium Abscessus Lung Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 18 Jun 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: RifabutinStandard 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. |
| Control Group | Experimental | Drug: No RifabutinStandard therapy: Amikacin, Imipenem, Tigecycline, Linezolid, and Clarithromycin or Azithromycin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Known hypersensitivity to rifabutin or intolerance to other study medications
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifabutinThe treatment group (received standard treatment plus Rifabutin, with the dosage adjusted according to weight and renal function) | Drug | Treatment Group |
| No Rifabutinthe control group (received standard treatment only). | Drug | Control Group |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifabutin and No Rifabutin in people with Mycobacterium Abscessus Lung Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.