Ignite Creation Date:
2024-05-06 @ 1:30 PM
Last Modification Date:
2024-10-26 @ 1:15 PM
Study NCT ID:
NCT04043325
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2019-07-31
Brief Title:
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
Sponsor:
University Childrens Hospital Zurich
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
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 myKIDS-STEP
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
myKIDS-STEP
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
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 particularly in CAP caused by Mycoplasma pneumoniae Mp Timely and reliable identification is critical for initiating effective and tailored antimicrobial treatment However determining the causative pathogen of childhood CAP is complicated by the low yield of blood cultures and difficulty obtaining specimens from the lower respiratory tract of children Therefore clinicians attempt to detect potential pathogens in upper respiratory tract URT specimens knowing that children carry viruses and bacteria in their URT that may or may not be causative for the current pneumonia episode Consequently the interpretation of diagnostic tests performed with URT specimens is limited and may lead to unnecessary antimicrobial prescriptions
The hurdle in differentiating infection from carriage was documented recently for Mp a frequently reported pathogen underlying CAP in children worldwide up to 20-40 during epidemics Current diagnostic tests including polymerase chain reaction PCR of URT specimens or serology do not reliable differentiate between Mp infection and carriage Mp is found in the URT in up to 56 of healthy children These findings challenge recent epidemiological data indicating Mp as the most common bacterial cause of CAP in up to 23 of hospitalized US children aged 10-17 years A 4-fold increase in IgG antibody levels is still considered the gold standard for diagnosing M pneumoniae infection but has low sensitivity when eg compared with IgM seroconversion andor a 2-fold IgM increase In fact such a definition is also not helpful in acute clinical management as it requires acute and convalescent sera
Circulating antigen-specific B cell responses have been investigated in vaccine studies and demonstrated to be more rapid and shorter lived than antibody responses After exposure antigen-specific B cells proliferate and differentiate into antibody-secreting cells ASCs and memory B cells ASCs transiently circulate in the peripheral blood in the first days after an antigen encounter In a recent observational pilot study of children with CAP and healthy controls we showed that the detection of Mp-specific immunoglobulin Ig M ASCs by enzyme-linked immunospot ELISpot assay re-classified 15 of PCR-positive and 12 of IgM-seropositive study participants httpsdoiorg101164rccm201904-0860LE Thus the measurement of specific IgM ASCs by ELISpot assay is an innovative minimally invasive and rapid test method that optimises diagnosis of Mp CAP in children
In view of these promising first results the aim of this study is to establish the diagnosis of Mp infection by the measurement of Mp-specific ASCs by ELISpot in CAP patients enroled in the randomised placebo-controlled multi-centre effectiveness trial of adjunct betamethasone therapy KIDS-STEP study Protocol ID NCT03474991
The hurdle in differentiating infection from carriage was documented recently for Mp a frequently reported pathogen underlying CAP in children worldwide up to 20-40 during epidemics Current diagnostic tests including polymerase chain reaction PCR of URT specimens or serology do not reliable differentiate between Mp infection and carriage Mp is found in the URT in up to 56 of healthy children These findings challenge recent epidemiological data indicating Mp as the most common bacterial cause of CAP in up to 23 of hospitalized US children aged 10-17 years A 4-fold increase in IgG antibody levels is still considered the gold standard for diagnosing M pneumoniae infection but has low sensitivity when eg compared with IgM seroconversion andor a 2-fold IgM increase In fact such a definition is also not helpful in acute clinical management as it requires acute and convalescent sera
Circulating antigen-specific B cell responses have been investigated in vaccine studies and demonstrated to be more rapid and shorter lived than antibody responses After exposure antigen-specific B cells proliferate and differentiate into antibody-secreting cells ASCs and memory B cells ASCs transiently circulate in the peripheral blood in the first days after an antigen encounter In a recent observational pilot study of children with CAP and healthy controls we showed that the detection of Mp-specific immunoglobulin Ig M ASCs by enzyme-linked immunospot ELISpot assay re-classified 15 of PCR-positive and 12 of IgM-seropositive study participants httpsdoiorg101164rccm201904-0860LE Thus the measurement of specific IgM ASCs by ELISpot assay is an innovative minimally invasive and rapid test method that optimises diagnosis of Mp CAP in children
In view of these promising first results the aim of this study is to establish the diagnosis of Mp infection by the measurement of Mp-specific ASCs by ELISpot in CAP patients enroled in the randomised placebo-controlled multi-centre effectiveness trial of adjunct betamethasone therapy KIDS-STEP study Protocol ID NCT03474991
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None