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Host-pathogen interaction study on non-tuberculous mycobacteria in children

Host-pathogen interaction study on non-tuberculous mycobacteria in children - Children-NTM

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00000462
Enrollment
200
Registered
2011-02-10
Start date
2010-11-17
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

A31 I88

Interventions

Group 1: children with NTM Lymphadenitis Group 2: controls matched for sex, age, region

Sponsors

Universitätsklinikum Freiburg Institut für Immundefizienz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Children with NTM infection defined as follows: 1) Probable infection Unilaterarally enlarged lymph node >= 2cm in diameter plus TST skin test > 5 mm plus exclusion of tuberculosis/ malignant lymphoma/ bartonellosis 2) Confirmed NTM infection a) Lymph node biopsy with histology typical for mycobacteria plus positive culture or PCR for NTM or b) Draining lymphnode plus positive smear (culture or PCR) for NTM Controls will be matched by age, sex, region, and – if possible – by ethnicity. The second unmatched control group will consist of children with diagnosed Bartonella henselae infection (specific antibody (IgG) titre > 1:265 in the course of the disease).

Exclusion criteria

Exclusion criteria: 1) Lack of informed consent of parent(s) or lack of assent of patient 2) Malignom/lymphoma, lymphoproliferative disease, detection of other pathogens (particularly Bartonella henselae (by culture, PCR or serology), tuberculosis (IGRA, Ellispot or x-ray chest for TB exclusion), detection of acute infections with other pathogens by culture, PCR or serology (Toxoplasmosis, infections with actinomycetes, Nocardia, CMV, EBV, HIV). 3) Children hospitalized due to immune or infection related conditions will not be eligible as controls for this study

Design outcomes

Secondary

MeasureTime frame
Questionnaire data: Lifestyle and environmental risk factors for NTM infections Genetics: Frequency of genetic variants in candidate genes between NTM cases and controls Micronutrients: Differences in immuno-nutrients (zinc, selenium etc.) between NTM cases and controls (Determination through questionnaire data and blood sample and buccal swap taken at study entrance).

Primary

MeasureTime frame
Primary Target Variable Micronutrients: Differences in serum 25(OH)vitamin D2 and D3 levels between NTM-cases and controls DNA-Methylation: Differences in DNA-Methylation levels of selected antimycobacterial candidate genes between NTM-cases and controls (Determination through blood sample and buccal swap taken at study entrance).

Countries

Germany

Contacts

Public ContactPhilipp Henneke

Universitätsklinikum Freiburg Institut für Immundefizienz

philipp.henneke@uniklinik-freiburg.de+49761 270-77542

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026