Clinical trial NCT03613636: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Pneumonia
Mycoplasma Pneumonia
Antibody-secreting Cells
Enzyme-linked Immunospot (ELISpot)
Diagnosis
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 490
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: 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)
timeFrame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Secondary outcomes:
measure: Change in M. pneumoniae DNA levels in respiratory samples from inclusion (day 0) to 1-month follow-up (day 28)
timeFrame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
measure: 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)
timeFrame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
measure: 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)
timeFrame: At day 28 (follow-up)
Other outcomes:
Locations:
Study officials:
affiliation: University Children's Hospital, Zurich
name: Patrick M. Meyer Sauteur, MD
role: PRINCIPAL_INVESTIGATOR
References: