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Nontuberculous mycobacterial cervicofacial lymphadenitis in children; diagnostic performance of the Capilia MAC antibody Elisa test and possible portals of entry

Nontuberculous mycobacterial cervicofacial lymphadenitis in children; diagnostic performance of the Capilia MAC antibody Elisa test and possible portals of entry - NTM cervicofacial lymphadenitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56039
Enrollment
96
Registered
2019-06-13
Start date
2019-10-23
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Nontuberculous mycobacterial cervicofacial lymphadenitis/Atypical mycobacterial head and neck infcection of the lymph nodes

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
No minimum to 15 Years

Inclusion criteria

Inclusion criteria: Study group: • Age between 0-15 years • High clinical suspicion of NTM cervicofacial lymphadenitis, as defined by the following factors; - Cervicofacial lymphadenopathy for a period longer than 3 weeks - Typical clinical presentation as defined by Penn et al. (2011) - Negative serologic tests for other kinds of (sub) chronical lymphadenopathy: Epstein-Barr virus, cytomegalovirus, Bartonella species, Adenovirus, and toxoplasmosis - Ultrasonographically, hypoechoic lymph nodes, often with central necrosis, nodal matting and adjacent soft tissue oedema Control group: • Age between 0-15 years • Indication for surgery under general anesthesia

Exclusion criteria

Exclusion criteria: Study group: - Known immunodeficiencies - Usage of immunosuppressive drugs Control group: - Clinical suspicion of NTM cervicofacial lymphadenisis as defined above

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the Capilia mac antibody Elisa test in patients with a clinical suspicion for NTM cervicofacial lymphadenitis. A receiver operating characteristic curve will be constructed and the overall accuracy will be expressed by the area under the curve.

Secondary

MeasureTime frame
The assessment of microbial composition and identification of NTM in the oral cavity, nose, oropharynx and excised lymph node material.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)