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

Completed

• Conditions: Childhood Pneumonia; Mycoplasma Pneumonia; Diagnosis; Enzyme-linked Immunospot (ELISpot); Antibody-secreting Cells
• Interventions: Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]

• Registration Number: NCT03613636
• Lead Sponsor: University Children's Hospital, Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-03
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CAP cohort	Enzyme-linked immunospot (ELISpot) assay [Blood]	* Children of age 3 to 16 years; * In- and outpatients; * Clinically diagnosed community-acquired pneumonia (CAP).
Healthy control cohort	Enzyme-linked immunospot (ELISpot) assay [Blood]	* Healthy asymptomatic children of age 3 to 16 years; * undergoing an elective surgical procedure.
Family control cohort	Enzyme-linked immunospot (ELISpot) assay [Blood]	- Family members of index CAP patients.

Primary Outcome Measures

Name	Time	Method
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)	At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)	Enzyme-linked immunospot (ELISpot) assay and flow cytometry

Secondary Outcome Measures

Name	Time	Method
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)	Enzyme-linked immunosorbent assay (ELISA)
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)	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.
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)	PCR