MYTHIC
A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Swiss National Science Foundation
NIH
interventional
376
1 country
13
Study Start
January 28, 2025
Actual (reported)Primary Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2024
Actual (reported)March 22, 2024
Actual (reported)January 28, 2025
Actual (reported)November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
From enrollment assessed up to 28 days.
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
5 days of placebo
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, 5001, Switzerland
University of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, 4056, Switzerland
Meyer Sauteur PM, Krautter S, Ambroggio L, Seiler M, Paioni P, Relly C, Capaul R, Kellenberger C, Haas T, Gysin C, Bachmann LM, van Rossum AMC, Berger C. Improved Diagnostics Help to Identify Clinical Features and Biomarkers That Predict Mycoplasma pneumoniae Community-acquired Pneumonia in Children. Clin Infect Dis. 2020 Oct 23;71(7):1645-1654. doi: 10.1093/cid/ciz1059.
Meyer Sauteur PM, Truck J, van Rossum AMC, Berger C. Circulating Antibody-Secreting Cell Response During Mycoplasma pneumoniae Childhood Pneumonia. J Infect Dis. 2020 Jun 16;222(1):136-147. doi: 10.1093/infdis/jiaa062.
Christoph Berger, Prof. Dr. med.
University Children's Hospital, Zurich
First Submitted
February 26, 2024
First Posted
March 22, 2024
Study Start
January 28, 2025
Actual (reported)Overall clinical outcome
From enrollment until end of treatment at 5 days.
Time (days) to normalization of CAP-related symptoms
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
From enrollment assessed up to 28 days.
Time (days) to return to daily routine
From enrollment assessed up to 28 days.
Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report
From enrollment assessed up to 28 days.
Length of hospital stay (LOS)
From enrollment assessed up to 28 days.
Number of unscheduled medical visits
From enrollment assessed up to 28 days.
Proportion of patients (re-)treated with antibiotics for any reason
From enrollment assessed up to 28 days.
Contact the study team to confirm eligibility.
University Children's Hospital Bern, Switzerland
Bern, Canton of Bern, 3010, Switzerland
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, 1708, Switzerland
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, 1205, Switzerland
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, 6000, Switzerland
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, 9006, Switzerland
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, 1011, Switzerland
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, 8401, Switzerland
University Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, 8032, Switzerland
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
Zurich, Canton of Zurich, 8063, Switzerland
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
Bellinzona, Canton Ticino, 6500, Switzerland
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
Chur, Kanton Graubünden, 7000, Switzerland
Meyer Sauteur PM, Seiler M, Truck J, Unger WWJ, Paioni P, Relly C, Staubli G, Haas T, Gysin C, M Bachmann L, van Rossum AMC, Berger C. Diagnosis of Mycoplasma pneumoniae Pneumonia with Measurement of Specific Antibody-Secreting Cells. Am J Respir Crit Care Med. 2019 Oct 15;200(8):1066-1069. doi: 10.1164/rccm.201904-0860LE. No abstract available.
Meyer Sauteur PM, Beeton ML; European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC), and the ESGMAC Mycoplasma pneumoniae Surveillance (MAPS) study group. Mycoplasma pneumoniae: delayed re-emergence after COVID-19 pandemic restrictions. Lancet Microbe. 2024 Feb;5(2):e100-e101. doi: 10.1016/S2666-5247(23)00344-0. Epub 2023 Nov 23. No abstract available.
Kutty PK, Jain S, Taylor TH, Bramley AM, Diaz MH, Ampofo K, Arnold SR, Williams DJ, Edwards KM, McCullers JA, Pavia AT, Winchell JM, Schrag SJ, Hicks LA. Mycoplasma pneumoniae Among Children Hospitalized With Community-acquired Pneumonia. Clin Infect Dis. 2019 Jan 1;68(1):5-12. doi: 10.1093/cid/ciy419.
Williams DJ, Edwards KM, Self WH, Zhu Y, Arnold SR, McCullers JA, Ampofo K, Pavia AT, Anderson EJ, Hicks LA, Bramley AM, Jain S, Grijalva CG. Effectiveness of beta-Lactam Monotherapy vs Macrolide Combination Therapy for Children Hospitalized With Pneumonia. JAMA Pediatr. 2017 Dec 1;171(12):1184-1191. doi: 10.1001/jamapediatrics.2017.3225.
Biondi E, McCulloh R, Alverson B, Klein A, Dixon A, Ralston S. Treatment of mycoplasma pneumonia: a systematic review. Pediatrics. 2014 Jun;133(6):1081-90. doi: 10.1542/peds.2013-3729.
Gardiner SJ, Gavranich JB, Chang AB. Antibiotics for community-acquired lower respiratory tract infections secondary to Mycoplasma pneumoniae in children. Cochrane Database Syst Rev. 2015 Jan 8;1(1):CD004875. doi: 10.1002/14651858.CD004875.pub5.
Meyer Sauteur PM, Seiler M, Tilen R, Osuna E, von Wantoch M, Sidorov S, Aebi C, Agyeman P, Barbey F, Bielicki JA, Coulon L, Deubzer B, Donas A, Heininger U, Keitel K, Kohler H, Kottanattu L, Lauener R, Niederer-Loher A, Posfay-Barbe KM, Tomaske M, Wagner N, Zimmermann P, Zucol F, von Felten S, Berger C. A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia: trial protocol for the MYTHIC Study. Trials. 2024 Oct 3;25(1):655. doi: 10.1186/s13063-024-08438-6.
Primary Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 5, 2026
Record last verified: 2026-04
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