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

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.

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Key information

Conditions

Childhood Pneumonia Antibody-secreting Cells Bacterial Infections Bacterial Infections and Mycoses Diagnosis Disease Enzyme-linked Immunospot (ELISpot) Gram-Negative Bacterial Infections Infections Lung Diseases Mycoplasma Infections Mycoplasma Pneumonia Mycoplasmatales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Bacterial Pneumonia, Mycoplasma Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enzyme-linked immunospot (ELISpot) assay [Blood]

Diagnostic Test

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 names: Polymerase chain reaction (PCR) [Pharyngeal swab specimens], Enzyme-linked immunosorbent assay (ELISA) [Serum]

Primary outcomes

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)

Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)

Enzyme-linked immunospot (ELISpot) assay and flow cytometry

Secondary outcomes

Change in M. pneumoniae DNA levels in respiratory samples from inclusion (day 0) to 1-month follow-up (day 28)

Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)

PCR
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)

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study 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)

Acronym: myCAP

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Aug 3, 2018
Registry last updated: Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed