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

• Conditions: A31; I88; Infection due to other mycobacteria; Nonspecific lymphadenitis

• Registration Number: DRKS00000462
• Lead Sponsor: niversitätsklinikum Freiburg Institut für Immundefizienz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-10
• Study Completion: 2016-06-15
• Results First Posted: 2020-03-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 138

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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