To determine the relationship between tissue immune responses and the clinical course of mycobacterial infections.
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transcriptional profiling of skin biopsies to determine molecular changes in
immune responses at the site of TST or saline injection.
Secondary outcome
Immunohistopathology of skin biopsies to determine molecular changes in immune
responses at the site of TST or saline injection.
Background summary
Mycobacterial infections, both tuberculosis (TB) and non-tuberculous
mycobacterial infections (NTM), cause over 10 million cases yearly with a wide
range of disease manifestations. Treatment is complex, causes considerable
toxicity and is hampered by antimicrobial resistance. Therefore, adjunctive
therapeutic approaches to improve the treatment of TB and NTM infections are a
key research priority. The host immune responses to mycobacterial infections
play a vital part in determining the outcome. Immunodeficiency can result in an
overwhelming infection due to insufficient control of bacterial replication,
while on the other hand, exaggerated inflammatory responses may cause extensive
tissue damage and perpetuate disease. Identifying the drivers of these aberrant
immune responses using an in vivo model would provide valuable prognostic
information as well as a rationale for the use of adjunctive immune-targeting
therapies.
Study objective
To determine the relationship between tissue immune responses and the clinical
course of mycobacterial infections.
Study design
Observational cohort study.
Study burden and risks
Participation consists of tuberculin skin tests, saline injections, and skin
biopsies. 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 the tuberculin / anaesthetic and the possible development
of a scar at the injection site. The overall risk of harm is low.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Mycobacterial infection
Exclusion criteria
- Known type 1 hypersensitivity to tuberculin PPD RT23 SSI or one of the
excipients;
- History of a severe local reaction to tuberculin PPD RT23 SSI or similar
products;
- Hypersensitivity to lidocaine or local anaesthetics of the amide type or one
of the excipients;
- History of keloid scarring.
Design
Recruitment
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 | NL81270.091.22 |