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

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ClinicalTrials.gov Identifier: NCT03613636
Recruitment Status : Completed
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Childhood Pneumonia Mycoplasma Pneumonia Antibody-secreting Cells Enzyme-linked Immunospot (ELISpot) Diagnosis Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]

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Study Type : Observational
Actual Enrollment : 490 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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]
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]

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]
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]

Family control cohort
- Family members of index CAP patients.
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].
Other Names:
  • Polymerase chain reaction (PCR) [Pharyngeal swab specimens]
  • Enzyme-linked immunosorbent assay (ELISA) [Serum]




Primary Outcome Measures :
  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) [ 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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.


Biospecimen Retention:   Samples With DNA
  • Respiratory samples (pharyngeal swab specimens);
  • Peripheral venous bood (peripheral blood mononuclear cells (PBMCs) and serum).


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613636


Sponsors and Collaborators
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Patrick M. Meyer Sauteur, MD University Children's Hospital, Zurich
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Responsible Party: University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03613636    
Other Study ID Numbers: 2016-00148
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not yet defined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Pleuropneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial