Evaluation of Pathogenesis and Diagnosis of Mycoplasma Pneumoniae Community-acquired Pneumonia (CAP)

Diagnosis Clinical Trial

— myCAP  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03613636
• Other study ID #: 2016-00148
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: October 31, 2020

Study information

• Verified date: February 2024
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

CAP cohort:

• 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:

• Hospital-acquired pneumonia;

• Immunodeficiencies;

• Chronic lung disorders.

Related Conditions & MeSH terms

• Antibody-secreting Cells
• Childhood Pneumonia
• Diagnosis
• Disease
• Enzyme-linked Immunospot (ELISpot)
• Mycoplasma Infections
• Mycoplasma Pneumonia
• Pleuropneumonia
• Pneumonia
• Pneumonia, Mycoplasma

Intervention

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].

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in numbers of M. pneumoniae-specific ASCs and M. pneumoniae-specific INF-?-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)
Secondary	Change in M. pneumoniae DNA levels in respiratory samples from inclusion (day 0) to 1-month follow-up (day 28)	PCR	At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Secondary	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)	At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Secondary	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.	At day 28 (follow-up)