Diagnosis of Mycoplasma Pneumoniae Infection With Detection of Specific Antibody-secreting Cells in Community-acquired Pneumonia (CAP) Patients of the Randomised Placebo-controlled Multi-centre Effectiveness Trial of Adjunct Betamethasone Therapy

NCT04043325 | Unknown

• 1 other identifier: 2019-00425
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To compare presence and kinetics of Mycoplasma pneumoniae (Mp)-specific immunoglobulin (Ig) M antibody-secreting cells (ASCs) with Mp DNA and Mp-specific IgM antibodies in patients with community-acquired pneumonia (CAP) of the KIDS-STEP study.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Detection of Mp-specific IgM ASCs by ELISpot assay

  Diagnosis of Mp infection in CAP patients of the KIDS-STEP study with the detection of Mp-specific IgM ASCs by ELISpot assay at enrolment (day 1).

  Day 1 (at enrolment)

Secondary Outcomes (4)

• No detection of Mp-specific IgM ASCs by ELISpot assay

  Day 28

• Detection of Mp-specific DNA by PCR

  Day 28

• Detection of Mp-specific IgM by ELISA

  Day 28

• Detection of specific IgM ASCs against other pathogens by ELISpot assay

  Day 1

Interventions

Specific antibody-secreting cell (ASC) enzyme-linked immunspot (ELISpot) assay DIAGNOSTIC_TEST

Clinical samples (nasopharyngeal swabs and max. 5 ml blood) will be collected from patients enroled in the KIDS-STEP study (NCT03474991; children aged 1-10 years) at enrolment (day 1), at day 3, and at day 28.

Also known as: Specific enzyme-linked immunosorbent assay (ELISA), Specific polymerase chain reaction (PCR)

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children from age 1 year weighing at least 7 kilograms and up to a body weight of 35 kilograms and age below 10 years admitted to the hospital with signs and symptoms of CAP will be considered potentially eligible for participation.

You may qualify if:

• At least 12 months of age and younger than 10 years of age
• Body weight between 7 kg and 35 kg
• Admission to hospital (i.e. assignment of an inpatient case number)
• Clinical diagnosis of CAP (according to predefined criteria)
• Parent and/or child (as age-appropriate) willing to accept all possible randomised allocations and to be contacted by telephone weekly up to and including at 4 weeks after randomisation
• Informed consent form for trial participation signed by parent

You may not qualify if:

• Presence of local chest complications
• Chronic underlying disease associated with an increased risk of very severe CAP or CAP of unusual aetiology
• Bilateral wheezing without focal chest signs (most likely to represent respiratory tract infection affecting the medium airways, i.e. not pneumonia)
• Inability to tolerate oral medication
• Documented allergy or any other known contraindication to any trial medication
• Subacute or chronic conditions requiring higher betamethasone equivalent or known primary or secondary adrenal insufficiency
• Known diabetes mellitus (type 1)
• Hospitalisation within the last two weeks preceding current admission
• Exposure to systemic corticosteroids with completion of treatment \<2 weeks from enrolment (courses of up to 7 days) or \<4 weeks from enrolment (courses of \>7 days)
• Transfer for any reason to a non-participating hospital directly from the paediatric emergency department
• Parent are unlikely to be able to reliably participate in telephone follow-up because of significant language barriers
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, and other dependent persons.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• University Children's Hospital Basel: collaborator
• Ostschweizer Kinderspital: collaborator

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal specimen, blood sample

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Enzyme-Linked Immunospot Assay

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

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

Central Study Contacts

Patrick M. Meyer Sauteur, MD PhD

CONTACT

+41442667896; patrick.meyer@kispi.uzh.ch

Study Design

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

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: May 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)