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

NCT03613636 | Completed

• 1 other identifier: 2016-00148
• Study Type: observational
• Target: 490
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Childhood Pneumonia; Mycoplasma Pneumonia; Antibody-secreting Cells; Enzyme-linked Immunospot (ELISpot); Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• 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)

• 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)

Study Arms (3)

CAP cohort

* Children of age 3 to 16 years; * In- and outpatients; * Clinically diagnosed community-acquired pneumonia (CAP).

Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]

Healthy control cohort

* Healthy asymptomatic children of age 3 to 16 years; * undergoing an elective surgical procedure.

Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]

Family control cohort

\- Family members of index CAP patients.

Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]

Interventions

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 \[Nat Protoc 2009;4:461-9\].

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

CAP cohort; Family control cohort; Healthy control cohort

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Hospital-acquired pneumonia;
• Immunodeficiencies;
• Chronic lung disorders.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Biospecimen

Retention: SAMPLES WITH DNA

* Respiratory samples (pharyngeal swab specimens); * Peripheral venous bood (peripheral blood mononuclear cells (PBMCs) and serum).

MeSH Terms

Conditions

Pneumonia, Mycoplasma; Disease

Interventions

Enzyme-Linked Immunospot Assay; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mycoplasma Infections; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Enzyme-Linked Immunosorbent Assay; Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Patrick M. Meyer Sauteur, MD

  University Children's Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 3, 2018
• Study Start: May 1, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 22, 2024

Record last verified: 2024-02