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.
Mycoplasma pneumoniae (M. pneumoniae) is the most frequently detected bacterial pathogen in community-acquired pneumonia (CAP) in hospitalized U.S. 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 children's health. CAP accounts for more treatment days with antibiotics in children's hospitals in the U.S. 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 1:1 to receive a 5-day-treatment of macrolides (azithromycin) or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
376
Azithromycin Pfizer® powder for oral suspension will be used in the active comparator arm: 1 daily dose for 5 days, 10mg/kg/day on day 1 and 5mg/kg/day on days 2-5
Control comparator arm: 5 days of placebo
Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, Switzerland
ACTIVE_NOT_RECRUITINGUniversity of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, Switzerland
RECRUITINGUniversity Children's Hospital Bern, Switzerland
Bern, Canton of Bern, Switzerland
RECRUITINGDepartment of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, Switzerland
NOT_YET_RECRUITINGChildren's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, Switzerland
NOT_YET_RECRUITINGChildren's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, Switzerland
RECRUITINGChildren's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
RECRUITINGDepartment of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, Switzerland
NOT_YET_RECRUITINGDepartment of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, Switzerland
RECRUITINGUniversity Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
RECRUITING...and 3 more locations
Co-primary outcome: days to normalization of all vital signs
Time (days) to normalization of all vital signs for at least 24h (efficacy), defined as temperature \<38.0°C, respiratory rate and heart rate within age-specific reference ranges, and peripheral oxygen saturation (SpO2) on room air ≥93% assessed up to 28 days.
Time frame: From enrollment until normalization of all vital signs for at least 24h assessed up to 28 days.
Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status
CAP-related change in patient care status within 28 days (safety), such as (re-)admission or ICU transfer assessed up to 28 days.
Time frame: From enrollment assessed up to 28 days.
Overall clinical outcome
Overall clinical outcome based on benefits and harms (DOOR/RADAR approach) according to documentation of clinical response (normalization of all VS) and solicited adverse events (AEs) 1x/24h at the end of treatment (day 5) and each FUP visit.
Time frame: From enrollment until end of treatment at 5 days.
Time (days) to normalization of CAP-related symptoms
Time (days) to normalization of CAP-related symptoms assessed up to 28 days.
Time frame: From enrollment until normalization of CAP-related symptoms assessed up to 28 days.
Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being
QoL assessment of the patient's family with the pediatric quality of life inventory TM (PedsQLTM) family impact module and generic core scales questionnaire until day 28.
Time frame: From enrollment assessed up to 28 days.
Time (days) to return to daily routine
Time (days) to return to daily routine, defined as return to childcare/school/work of patients and their families.
Time frame: From enrollment assessed up to 28 days.
Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report
Development of Mp-associated extrapulmonary manifestations within 28 days after randomization based on clinical examination and/or parent report.
Time frame: From enrollment assessed up to 28 days.
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