Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05676138 |
| Other study ID # |
2017-2154 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
December 2022 |
| Source |
Seoul National University Hospital |
| Contact |
Nakwon Kwak, MD |
| Phone |
82-2072-0616 |
| Email |
n.kwak[@]snu.ac.kr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Investigating the PK and PD indices in patients with M. abscessus complex-PD who will be
treated with a currently recommended regimen, minimum inhibitory concentrations of organism,
and their relation with clinical outcomes
Description:
Nontuberculous mycobacteria (NTM), consisting of more than 200 mycobacteria other than M.
tuberculosis and M. leprae, is an environmental organism, which can be isolated from soil,
dust and water. NTM can cause chronic diseases in human and the most common manifestation is
pulmonary disease (PD) . During the last decades, the burden of NTM-PD in rapidly increasing
in global. In South Korea, the incidence has increased from 1.0 per 100,000 population in
2003 to 17.9 per 100,00 population in 2016.
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.
