An observational study in Childhood Pneumonia, Mycoplasma Pneumonia and Antibody-secreting Cells, sponsored by University Children's Hospital, Zurich. Completed. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by University Children's Hospital, Zurich · Observational
To investigate the Mycoplasma pneumoniae-specific circulating antibody-secreting cell (ASC) response and Mycoplasma pneumoniae-specific interferon (INF)-γ-secreting T cell response, along with polymerase chain reaction (PCR) and serology, in a cohort of children with community-acquired pneumonia (CAP) and controls.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 490 is above the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
CAP cohort:
There will be a consecutive ongoing recruitment through the project leader or instructed physicians of the department of infectious diseases and emergency in daily clinical practice.
Healthy control cohort:
The project leader will be informed by the local surgeons about a planned elective surgical procedure, unrelated to respiratory tract disease, and will include children during the pre-operation discussion. Samples will be collected by the anaesthesist prior to the start of the surgical procedure, while the child is under general anaesthesia and has an intravenous line. In a subgroup of such children undergoing planned adenotomy, the removed adenoids will be collected after surgery.
Family control cohort:
Family members will be included simultaneously with the index CAP patients.
CAP cohort:
Healthy control cohort:
Family control cohort:
Exclusion Criteria:
* Children of age 3 to 16 years; * In- and outpatients; * Clinically diagnosed community-acquired pneumonia (CAP).
Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]
* Healthy asymptomatic children of age 3 to 16 years; * undergoing an elective surgical procedure.
Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]
- Family members of index CAP patients.
Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]
The ASC ELISpot will be developed based on the improved methods recently described \[Nat Protoc 2013;8:1073-87\]. This protocol allows rapid (6-8 h) detection of specific ASCs in small volumes (1-2 ml) of blood. M. pneumoniae protein P1 (50 μl/ml) will be used as antigen. The optimal concentration of coating antigen will be assessed in advance in two-fold serial dilutions for clear spot definition. The M. pneumoniae-specific T cell ELISpot will be developed based on methods recently described \[Nat Protoc 2009;4:461-9\].
Also known as: Polymerase chain reaction (PCR) [Pharyngeal swab specimens], Enzyme-linked immunosorbent assay (ELISA) [Serum]
Change in numbers of M. pneumoniae-specific ASCs and M. pneumoniae-specific INF-γ-secreting T cells in blood from inclusion (day 0) to 1-month follow-up (day 28)
Enzyme-linked immunospot (ELISpot) assay and flow cytometry
Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Change in M. pneumoniae DNA levels in respiratory samples from inclusion (day 0) to 1-month follow-up (day 28)
PCR
Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Change in total and M. pneumoniae-specific antibody levels (immunoglobulin (Ig)G, IgM, IgA) from inclusion (day 0) to 1-month follow-up (day 28)
Enzyme-linked immunosorbent assay (ELISA)
Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Outcome of community-acquired pneumonia (CAP) assessed by clinical assessment of body temperature (°C) and respiratory rate (per minute) at 1-month follow-up (day 28)
Clinical assessment of body temperature (°C) and respiratory rate (per minute), with worse outcome defined as body temperature more than 38.5°C and respiratory rate according to age more than 40/min for 3 years, more than 34/min for 4-5 years, more than 30/min for 6-12 years, and more than 16/min for 13-18 years.
Time frame: At day 28 (follow-up)
No study locations are listed for this record.
Plan to share: Undecided — Not yet defined.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich