A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
- Conditions
- Mycoplasma PneumoniaeCommunity Acquired Pneumonia in ChildrenMycoplasma Pneumoniae Pneumonia
- Interventions
- Drug: Placebo
- Registration Number
- NCT06325293
- Lead Sponsor
- Christoph Berger
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 376
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo arm Placebo 5 days of placebo IMP arm Azithromycin Pfizer® Azithromycin Pfizer® powder for oral suspension: 1 daily dose for 5 days, 10mg/kg/day on day 1 and 5mg/kg/day on days 2-5
- Primary Outcome Measures
Name Time Method Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status From enrollment assessed up to 28 days. CAP-related change in patient care status within 28 days (safety), such as (re-)admission or ICU transfer assessed up to 28 days.
Co-primary outcome: days to normalization of all vital signs From enrollment until normalization of all vital signs for at least 24h assessed up to 28 days. 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.
- Secondary Outcome Measures
Name Time Method Time (days) to normalization of CAP-related symptoms From enrollment until normalization of CAP-related symptoms assessed up to 28 days. Time (days) to normalization of CAP-related symptoms assessed up to 28 days.
Time (days) to return to daily routine From enrollment assessed up to 28 days. Time (days) to return to daily routine, defined as return to childcare/school/work of patients and their families.
Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being From enrollment assessed up to 28 days. 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.
Overall clinical outcome From enrollment until end of treatment at 5 days. 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.
Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report From enrollment assessed up to 28 days. Development of Mp-associated extrapulmonary manifestations within 28 days after randomization based on clinical examination and/or parent report.
Trial Locations
- Locations (13)
Children's Hospital Aarau, Switzerland
🇨🇭Aarau, Aargau, Switzerland
University of Basel Children's Hospital, Switzerland
🇨🇭Basel, Basel-Stadt, Switzerland
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
🇨🇭Chur, Graubünden, Switzerland
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
🇨🇭Bellinzona, Ticino, Switzerland
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
🇨🇭Lausanne, Vaud, Switzerland
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
🇨🇭Winterthur, Zurich, Switzerland
University Children's Hospital Bern, Switzerland
🇨🇭Bern, Switzerland
Department of Pediatrics, Fribourg Hospital, Switzerland
🇨🇭Fribourg, Switzerland
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
🇨🇭Geneva, Switzerland
Children's Hospital of Central Switzerland, Switzerland
🇨🇭Luzern, Switzerland
Children's Hospital of Eastern Switzerland St. Gallen
🇨🇭St. Gallen, Switzerland
University Children's Hospital Zurich, Switzerland
🇨🇭Zurich, Switzerland
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
🇨🇭Zurich, Switzerland