Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-02-26
Brief Title:
A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia MYTHIC Study
Sponsor:
Christoph Berger
Organization:
University Childrens Hospital Zurich
Study Overview
Official Title:
A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
MYTHIC
Brief Summary:
The goal of this clinical trial is to compare a placebo a look-alike substance that contains no active drug with a commonly used antibiotic in children with Mycoplasma pneumoniae a specific bacterium induced community-acquired pneumonia The main question it aims to answer is
Is antibiotic treatment needed in Mycoplasma pneumoniae a specific bacterium induced pneumonia
Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy
Researchers will then compare the length of symptoms between the placebo and the antibiotic group
Is antibiotic treatment needed in Mycoplasma pneumoniae a specific bacterium induced pneumonia
Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy
Researchers will then compare the length of symptoms between the placebo and the antibiotic group
Detailed Description:
Mycoplasma pneumoniae M pneumoniae is the most frequently detected bacterial pathogen in community-acquired pneumonia CAP in hospitalized US children Prior to the COVID-19 pandemic M pneumoniae was responsible for 8-28 of childhood CAP and thus was substantially contributes to CAP being a leading cause of hospitalization in high-income settings and worldwide morbidity and mortality After the corona virus disease COVID-19 pandemic M pneumoniae and its delayed re-emergence remains a thread to childrens health CAP accounts for more treatment days with antibiotics in childrens hospitals in the US than any other condition Macrolides are the first-line treatment for M pneumoniae infection Still there is a lack of evidence for macrolides the effectiveness in the treatment of M pneumoniae induced CAP simultaneously there is an alarmingly increasing antimicrobial resistance among M pneumoniae Therefore childhood CAP and especially M pneumoniae is an important target for antimicrobial stewardship efforts and cost-effectiveness considerations
The MYTHIC Study is a randomized double-blind placebo-controlled multicenter non-inferiority trial in 13 Swiss pediatric centers Previously healthy ambulatory and hospitalized children aged 3-17 years with clinically diagnosed CAP will be screened for a M pneumoniae infection with Immunoglobulin M IgM lateral flow assay Patients will be randomized 11 to receive a 5-day-treatment of macrolides azithromycin or placebo
The MYTHIC Study is a randomized double-blind placebo-controlled multicenter non-inferiority trial in 13 Swiss pediatric centers Previously healthy ambulatory and hospitalized children aged 3-17 years with clinically diagnosed CAP will be screened for a M pneumoniae infection with Immunoglobulin M IgM lateral flow assay Patients will be randomized 11 to receive a 5-day-treatment of macrolides azithromycin or placebo
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 207286 | OTHER_GRANT | Swiss National Science Foundation | None |