Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia
Conditions
Keywords
Mycoplasma pneumoniae, community-acquired pneumonia, randomized controlled trial, Investigator Initiated Clinical Trial (IICT), Paediatric pneumonia, children, placebo, macrolides
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.
Interventions
DRUGAzithromycin Pfizer®
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
DRUGPlacebo
Control comparator arm: 5 days of placebo
Sponsors
Christoph Berger
Swiss National Science Foundation
Swiss Clinical Trial Organisation
SwissPedNet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial.
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
for screening phase: * Children aged 3-17 years (from 3rd up to 18th birthday) presenting to the emergency department (ED) who will be managed ambulatory or will be admitted to general ward. * Clinical diagnosis of CAP: 1. Diagnosis defined as the treating physician's documented diagnosis of CAP; AND 2. Fever ≥38.0°C (measured by any method \[i.e., ear, axillary, rectal, or forehead site\] in the ED or via parent report observed in the last 24h); AND 3. Tachypnea (defined as respiratory rate (RR) above age-specific reference value) during the assessment in ED (triage or clinical examination). * Written screening consent for participation in screening phase signed by parents/legal guardians and the patient if ≥14 years of age. Additional inclusion criteria for intervention phase: * Positive Mp screening test result with the Mp IgM lateral flow assay (LFA) (grade 2 or 3). * Written informed consent for participation in intervention phase signed by parents or legal guardians and the patient if ≥14 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Switzerland
Contacts
CONTACTPatrick M Meyer Sauteur, PD Dr. Dr. med.
CONTACTMargarete Von Wantoch, Dr. rer. nat.
STUDY_CHAIRChristoph Berger, Prof. Dr. med.
University Children's Hospital, Zurich
Outcome results
None listed