Diagnosis of Mycoplasma Pneumoniae Infection With Detection of Specific Antibody-secreting Cells … (NCT04043325) | Clinical Trial Compass
UnknownNot Applicable
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
Switzerland100 participantsStarted 2019-05-20
Plain-language 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.
Who can participate
Age range1 Year – 10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 reli…
What they're measuring
1
Detection of Mp-specific IgM ASCs by ELISpot assay