Non-Tuberculous Mycobacterial Skin and Soft Tissue Infections: Using a Site-of-Disease Approach to Understand Pathophysiology and Improve Outcome

Non-Tuberculous Mycobacterial Skin and Soft Tissue Infections: Using a Site-of-Disease Approach to Understand Pathophysiology and Improve Outcome - MyCoS-SSTI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56521

Enrollment

Registered

2023-10-03

Start date

2024-03-21

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-tuberculous mycobacterial skin and soft tissue infections

Interventions

Niet van toepassing

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Non-tuberculous mycobacterial skin and/or soft tissue infection

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Transcriptional profiling of skin biopsies to determine the local immune response to NTM and the changes of the immune response during treatment.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Contacts

Public ContactA Laarhoven

Radboud Universitair Medisch Centrum

arjan.vanlaarhoven@radboudumc.nl0243098436

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)