To identify clinical and immunological parameters that predict the course of disease of non-tuberculous mycobacterial skin and soft tissue infections.
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transcriptional profiling of skin biopsies to determine the local immune
response to NTM and the changes of the immune response during treatment.
Secondary outcome
Secondary parameters will be:
- Clinical:
o Objective quantification of disease extent (affected area) using medical
photography at baseline, after 8 weeks of treatment, at the moment of treatment
failure (if applicable), and at the end of treatment;
o Histopathology of affected tissue at baseline, after 8 weeks of treatment,
and at the moment of treatment failure (if applicable).
- Microbiological:
o Species determination and antibiotic susceptibility profile;
o Mycobacterial burden at baseline, after 8 weeks of treatment, and at the
moment of treatment failure (if applicable).
- Pharmacological
o Plasma antibiotic levels after 8 weeks of treatment;
o Intracellular antibiotic levels after 8 weeks of treatment;
o Site-of-disease (i.e. skin) antibiotic levels after 8 weeks of treatment.
- Immunological
o Peripheral blood immunological phenotyping at baseline, after 8 weeks of
treatment, at the moment of treatment failure (if applicable), and at the end
of treatment;
- Patient reported
o Patient reported experience measures (PREM) after 8 weeks, 26 weeks (6
months), and end of treatment;
o Patient reported outcome measures (PROM) after 8 weeks, 26 weeks (6 months),
and end of treatment.
Background summary
Non-tuberculous mycobacteria (NTM) can cause debilitating skin and soft tissue
infections (SSTI). NTM SSTI incidence rises with an aged population and
increased use of immunosuppression. These infections require 4-6 months of
multidrug antibiotic regimens minimally. Still, non-response or worsening of
skin lesions occur frequently, because antibiotics fail or too much
inflammation occurs. We think that differences in the patients* immune systems,
so-called patient endotypes, drive these diverging treatment courses. We
currently do not know which immune processes in the skin contribute to these
processes. We also lack target concentrations of the key antibiotics
azithromycin and clofazimine in the skin, where they need to kill the NTM.
Study objective
To identify clinical and immunological parameters that predict the course of
disease of non-tuberculous mycobacterial skin and soft tissue infections.
Study design
Multi-center, observational cohort study.
Study burden and risks
Participation consists of skin biopsies of both affected (6 to 9 biopsies) as
non-affected (1 biopsy) tissue and blood sampling. Blood sampling will be
conducted during routinely planned venipunctures to minimize the burden. There
is no clinical benefit to be expected from participation. The burden associated
with participation consists of short-term pain or discomfort during injection
of anaesthetic or venipunctures, the extra blood volume drawn, and the possible
development of a scar of the biopsy site. The overall risk of participation is
low.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Non-tuberculous mycobacterial skin and/or soft tissue infection
Exclusion criteria
HIV co-infection
Hypersensitivity to lidocaine, local anaesthetics of the amide type, or one of
the excipients
Factors precluding antimycobacterial treatment
Estimated life expectancy < 3 months
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85356.091.23 |