PK and PD of Antibiotics for Treatment of Mycobacterium Abscessus Pulmonary Disease
NCT ID: NCT05676138
Last Updated: 2023-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2023-01-01
2024-12-31
Brief Summary
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Detailed Description
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M. abscessus complex is a group of rapidly growing mycobacteria (RGM). M. abscessus complex can be divided into three subspecies: M. abscessus subspecies abscessus (hereafter, referred to as M. abscessus), M. abscessus subspecies massiliense (M. massiliense), and M. abscessus subspecies bolletii (M. bolletii). Among the RGMs, M. abscessus complex is the most common pathogen for respiratory infection. With its distinctive surface properties and type VII secretion system (ESX-4), M. abscessus complex can cause progressive infection in patients with structural lung diseases such as cystic fibrosis.
Treatment of M. abscessus complex is extremely difficult. M. abscessus complex is generally resistant to most classes of antibiotics due to decreased cell wall permeability, induction of efflux pumps, and modification of drug targets. Especially, the presence of function erm(41) gene in M. abscessus confers inducible resistance to macrolide, which is the core drug of NTM-PD. As a result, multidrug regimens including at least three or four active drugs based on in vitro susceptibility are recommended for M. abscessus complex-PD.
Even though these complex and intensified treatments are administered in real clinical practice, the optimal drugs, dosage and duration of therapy are still not understood. Moreover, treatment outcomes are still unsatisfactory. According to the dataset from 303 patients with M. abscessus complex-PD, the treatment success rates were 33.0% for M. abscessus and 56.7% for M. massiliense, respectively. The unfavorable outcomes of currently recommended regimens are partly explained by an incomplete understanding of the relationship between pharmacokinetics (PK) of drugs used, in vitro susceptibility and treatment outcomes. To improve treatment outcomes, it should be preceded to figure out the potential efficacy of currently recommended regimens for M. abscessus complex-PD.
This will be performed as a prospective pharmacokinetic study for patients with M. abscessus complex-PD. Patients, who are scheduled to initiate treatment for M. abscessus complex-PD between 1 January 2023 and 31 December 2024 at Seoul National University Hospital, will be the subject of study. The size of population is estimated to be 40.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Measuring PK and PD indices in patients who receive conventional treatment
Measuring plasma concentration of commonly used antibiotics in NTM-PD
Eligibility Criteria
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Inclusion Criteria
* Fulfilling the criteria of NTM-PD (1, 13), for which causative organism belongs to M. abscessus or M. massiliense
* Needing a new antibiotic treatment for M. abscessus complex-PD due to symptomatic aggravation, radiographic progression or both (those who have previous history of treatment are eligible)
* Consenting to receive antibiotic treatment based on currently recommended regimens (1, 13) and to participate in this study
Exclusion Criteria
* Having end-stage renal disease needing hemodialysis, chronic liver disease, or active malignancy needing treatment during the treatment period
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jae-Joon Yim
Professor
Principal Investigators
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Jae-Joon Yim, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Central Contacts
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Other Identifiers
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2017-2154
Identifier Type: -
Identifier Source: org_study_id
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