Status:
UNKNOWN
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
Lead Sponsor:
University Children's Hospital, Zurich
Collaborating Sponsors:
University Children's Hospital Basel
Ostschweizer Kinderspital
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
1-10 years
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-acqu...
Detailed Description
Community-acquired pneumonia (CAP) is a common serious infection and a leading cause of hospitalisation in children. Knowledge about the underlying pathogen is a major unmet clinical need, particularl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04043325
Start Date
May 20 2019
End Date
December 31 2021
Last Update
November 13 2020
Active Locations (1)
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1
University Children's Hospital Zurich
Zurich, Switzerland, 8032