myCAP
The Role of Adaptive Immune Responses to Mycoplasma Pneumoniae in Pathogenesis and Diagnosis of Community-acquired Pneumonia (CAP) in Children: an Observational Single-center Study (myCAP Study)
Sponsor study identifier
Secondary identifiers
NIH
observational
490
0 countries
N/A
Study Start
May 1, 2016
Actual (reported)Primary Completion
October 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2016
Actual (reported)July 6, 2018
Actual (reported)August 3, 2018
Actual (reported)October 31, 2020
Actual (reported)October 31, 2020
Actual (reported)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
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)
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)
At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
* Children of age 3 to 16 years; * In- and outpatients; * Clinically diagnosed community-acquired pneumonia (CAP).
* Healthy asymptomatic children of age 3 to 16 years; * undergoing an elective surgical procedure.
\- Family members of index CAP patients.
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 \[Nat Protoc 2009;4:461-9\].
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
* Respiratory samples (pharyngeal swab specimens); * Peripheral venous bood (peripheral blood mononuclear cells (PBMCs) and serum).
Patrick M. Meyer Sauteur, MD
University Children's Hospital, Zurich
490 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2018
First Posted
August 3, 2018
Study Start
May 1, 2016
Actual (reported)Etiology of Community Acquired Pneumonia
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)
At day 28 (follow-up)
Contact the study team to confirm eligibility.
Primary Completion
October 31, 2020
Actual (reported)Study Completion
October 31, 2020
Actual (reported)Last Updated
February 22, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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