Childhood PneumoniamyCAPNCT03613636
Evaluation of Pathogenesis and Diagnosis of Mycoplasma Pneumoniae Community-acquired Pneumonia (CAP)
An observational study of Childhood Pneumonia and Mycoplasma Pneumonia, run by University Children's Hospital, Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Childhood Pneumonia, Mycoplasma Pneumonia, Antibody-secreting Cells
- What is being tested?
- Enzyme-linked immunospot (ELISpot) assay [Blood]
- How many people
- 490 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Hospital-acquired pneumonia;
- Immunodeficiencies;
- Chronic lung disorders.
About this study
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)
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
- Being tested
- Enzyme-linked immunospot (ELISpot) assay [Blood]
- Medical subject headings
- Pneumonia, Mycoplasma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzyme-linked immunospot (ELISpot) assay [Blood]Diagnostic test
Also called Polymerase chain reaction (PCR) [Pharyngeal swab specimens], Enzyme-linked immunosorbent assay (ELISA) [Serum]
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].
| Study group | Role | What they receive |
|---|---|---|
| CAP cohort | * Children of age 3 to 16 years;
* In- and outpatients;
* Clinically diagnosed community-acquired pneumonia (CAP). Receives: 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. Receives: Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood] | |
| Family control cohort | - Family members of index CAP patients. Receives: Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood] |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
PCR
Measured: 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)
Enzyme-linked immunosorbent assay (ELISA)
Measured: 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)
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.
Measured: At day 28 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 May 2016
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick M. Meyer Sauteur, MD, Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613636
- Sponsor's protocol ID
- 2016-00148
- Other IDs
- 2016
- Acronym
- myCAP
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2018
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet defined.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03613636
- Acronym / sponsor ID
- myCAP / 2016-00148
- Conditions
- Childhood Pneumonia, Mycoplasma Pneumonia, Antibody-secreting Cells, Enzyme-linked Immunospot (ELISpot), Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAP cohort | – | Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]* Children of age 3 to 16 years; * In- and outpatients; * Clinically diagnosed community-acquired pneumonia (CAP). |
| Healthy control cohort | – | Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]* Healthy asymptomatic children of age 3 to 16 years; * undergoing an elective surgical procedure. |
| Family control cohort | – | Diagnostic Test: Enzyme-linked immunospot (ELISpot) assay [Blood]- Family members of index CAP patients. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Children of age 3 to 18 years;
- In- and outpatients;
- Clinically diagnosed community-acquired pneumonia (CAP);
- Healthy asymptomatic children of age 3 to 18 years undergoing an elective surgical procedure;
- Family members of index CAP patients.
Key exclusion criteria (3 listed)
- Hospital-acquired pneumonia;
- Immunodeficiencies;
- Chronic lung disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzyme-linked immunospot (ELISpot) assay [Blood]Also: Polymerase chain reaction (PCR) [Pharyngeal swab specimens], Enzyme-linked immunosorbent assay (ELISA) [Serum]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]. | Diagnostic test | CAP cohort, Family control cohort, Healthy control cohort |
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)
Time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)
Enzyme-linked immunospot (ELISpot) assay and flow cytometry
3 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided. Not yet defined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick M. Meyer Sauteur, MD principal investigator
University Children's Hospital, Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Pneumonia and Mycoplasma Pneumonia, run by University Children's Hospital, Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: At day 0 (inclusion, disease presentation) and at day 28 (follow-up, disease resolution)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.