protocolSection identificationModule nctId: NCT06325293, orgStudyIdInfo id: 2023-01295, secondaryIdInfos id: 207286, type: OTHER_GRANT, domain: Swiss National Science Foundation, briefTitle: A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study, acronym: MYTHIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Christoph Berger, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Community Acquired Pneumonia in Children, conditions: Mycoplasma Pneumoniae, conditions: Mycoplasma Pneumoniae Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 376, type: ESTIMATED, armsInterventionsModule interventions name: Azithromycin Pfizer®, interventions name: Placebo, outcomesModule primaryOutcomes measure: Co-primary outcome: days to normalization of all vital signs, primaryOutcomes measure: Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status, secondaryOutcomes measure: Overall clinical outcome, secondaryOutcomes measure: Time (days) to normalization of CAP-related symptoms, secondaryOutcomes measure: Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being, secondaryOutcomes measure: Time (days) to return to daily routine, secondaryOutcomes measure: Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report, otherOutcomes measure: Length of hospital stay (LOS), otherOutcomes measure: Number of unscheduled medical visits, otherOutcomes measure: Proportion of patients (re-)treated with antibiotics for any reason, otherOutcomes measure: Side effects/AEs/serious AE (SAE)s of investigational medicinal product (IMP), otherOutcomes measure: Microbiological indicators, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Aarau, Switzerland, city: Aarau, state: Aargau, zip: 5001, country: Switzerland, contacts name: Henrik Köhler, Prof. Dr. med., role: CONTACT, phone: 0041 62 838 41 41, email: Henrik.Koehler@ksa.ch, contacts name: Henrik Köhler, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.39254, lon: 8.04422, locations facility: University of Basel Children's Hospital, Switzerland, city: Basel, state: Basel-Stadt, zip: 4056, country: Switzerland, contacts name: Julia A Bielicki, PD Dr. Dr. med., role: CONTACT, phone: 0041 61 704 12 12, email: julia.bielicki@ukbb.ch, contacts name: Julia A Bielicki, PD Dr. Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Ulrich Heiniger, Prof. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, locations facility: Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland, city: Chur, state: Graubünden, zip: 7000, country: Switzerland, contacts name: Beate Deubzer, Dr. med., role: CONTACT, phone: 0041 81 256 61 11, email: beate.deubzer@ksgr.ch, contacts name: Beate Deubzer, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.84986, lon: 9.53287, locations facility: Children's Hospital of Eastern Switzerland St. Gallen, city: St. Gallen, state: Saint Gallen, zip: 9006, country: Switzerland, contacts name: Anita Niederer-Loher, Dr. med., role: CONTACT, phone: 0041 71 243 71 11, email: anita.niederer@kispisg.ch, contacts name: Anita Niederer-Loher, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42391, lon: 9.37477, locations facility: Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland, city: Bellinzona, state: Ticino, zip: 6500, country: Switzerland, contacts name: Lisa Kottanattu, Dr. med., role: CONTACT, phone: 0041 91 811 91 11, email: Lisa.Kottanattu@eoc.ch, contacts name: Lisa Kottanattu, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.19278, lon: 9.01703, locations facility: Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland, city: Lausanne, state: Vaud, zip: 1011, country: Switzerland, contacts name: Ludivine Coulon, Dr. med., role: CONTACT, phone: 0041 21 314 11 11, email: Ludivine.Coulon@chuv.ch, contacts name: Ludivine Coulon, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.516, lon: 6.63282, locations facility: Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland, city: Winterthur, state: Zurich, zip: 8401, country: Switzerland, contacts name: Andreas Jung, Dr. med., role: CONTACT, phone: 0041 52 266 41 44, email: andreas.jung@ksw.ch, contacts name: Andreas Jung, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.50564, lon: 8.72413, locations facility: University Children's Hospital Bern, Switzerland, city: Bern, zip: 3010, country: Switzerland, contacts name: Philipp Agyeman, PD Dr. med., role: CONTACT, phone: 0041 31 632 21 11, email: Philipp.Agyeman@insel.ch, contacts name: Philipp Agyeman, PD Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Kristina Keitel, PD Dr. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Department of Pediatrics, Fribourg Hospital, Switzerland, city: Fribourg, zip: 1708, country: Switzerland, contacts name: Petra Zimmermann, PD Dr. Dr. med., role: CONTACT, phone: 0041 26 306 00 00, email: petra.zimmermann@unifr.ch, contacts name: Petra Zimmermann, PD Dr. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.80237, lon: 7.15128, locations facility: Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland, city: Geneva, zip: 1205, country: Switzerland, contacts name: Noémie Wagner, Dr. med., role: CONTACT, phone: 0041 22 372 40 00, email: Noemie.Wagner@hcuge.ch, contacts name: Noémie Wagner, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.20222, lon: 6.14569, locations facility: Children's Hospital of Central Switzerland, Switzerland, city: Luzern, zip: 6000, country: Switzerland, contacts name: Alex Donas, Dr. med., role: CONTACT, phone: 0041 41 205 31 66, email: alex.donas@luks.ch, contacts name: Alex Donas, Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.05048, lon: 8.30635, locations facility: University Children's Hospital Zurich, Switzerland, city: Zurich, zip: 8032, country: Switzerland, contacts name: Michelle Seiler, PD Dr. med, role: CONTACT, phone: 0041 44 266 71 11, email: Michelle.Seiler@kispi.uzh.ch, contacts name: Michelle Seiler, PD Dr. med, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Department of Pediatrics, Triemli Hospital Zurich, Switzerland, city: Zurich, zip: 8063, country: Switzerland, contacts name: Maren Tomaske, Prof. Dr. med., role: CONTACT, phone: 0041 44 416 11 11, email: Maren.Tomaske@stadtspital.ch, contacts name: Maren Tomaske, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False