Evaluation of Pathogenesis and Diagnosis of Mycoplasma Pneumoniae Community-acquired Pneumonia (CAP)
NCT ID: NCT03613636
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
490 participants
OBSERVATIONAL
2016-05-01
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CAP cohort
* Children of age 3 to 16 years;
* In- and outpatients;
* Clinically diagnosed community-acquired pneumonia (CAP).
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 \[Nat Protoc 2009;4:461-9\].
Healthy control cohort
* Healthy asymptomatic children of age 3 to 16 years;
* undergoing an elective surgical procedure.
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 \[Nat Protoc 2009;4:461-9\].
Family control cohort
\- Family members of index CAP patients.
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 \[Nat Protoc 2009;4:461-9\].
Interventions
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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 \[Nat Protoc 2009;4:461-9\].
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children of age 3 to 18 years;
* In- and outpatients;
* Clinically diagnosed community-acquired pneumonia (CAP);
Healthy control cohort:
\- Healthy asymptomatic children of age 3 to 18 years undergoing an elective surgical procedure;
Family control cohort:
\- Family members of index CAP patients.
Exclusion Criteria
* Immunodeficiencies;
* Chronic lung disorders.
3 Years
ALL
Yes
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Principal Investigators
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Patrick M. Meyer Sauteur, MD
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Zurich
Other Identifiers
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2016-00148
Identifier Type: -
Identifier Source: org_study_id
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