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

Brief Title

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

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)

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.
    



Study Type

Observational


Primary Outcome

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)

Secondary Outcome

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

Condition

Childhood Pneumonia

Intervention

Enzyme-linked immunospot (ELISpot) assay [Blood]

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

490

Start Date

May 1, 2016

Completion Date

April 30, 2017

Primary Completion Date

April 30, 2017

Eligibility 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.
      

Gender

All

Ages

3 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Patrick M. Meyer Sauteur, MD, , 



Administrative Informations


NCT ID

NCT03613636

Organization ID

2016-00148


Responsible Party

Sponsor

Study Sponsor

University Children's Hospital, Zurich


Study Sponsor

Patrick M. Meyer Sauteur, MD, Principal Investigator, University Children's Hospital, Zurich


Verification Date

July 2018