A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
NCT ID: NCT06325293
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
376 participants
INTERVENTIONAL
2025-01-28
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IMP arm
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
Azithromycin 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
Placebo arm
5 days of placebo
Placebo
Control comparator arm: 5 days of placebo
Interventions
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Azithromycin 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
Placebo
Control comparator arm: 5 days of placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongation\*; myasthenia gravis.
* Underlying comorbidities: Cystic fibrosis or other chronic lung disorders (excluding asthma), primary or secondary immunodeficiency, sickle-cell anemia, or severe cerebral palsy.
* History of recurrent pneumonia (two or more episodes) or severe pneumonia (ICU admission or complications of CAP such as lung abscess, effusion, and empyema) in lifetime.
* Antibiotic treatment against Mp within the previous 7 days, including macrolides, tetracyclines, or fluoroquinolones.
* Referral to ICU directly from the ED.
* Inability to take oral medication.
* Parents are unlikely to reliably complete follow up (FUP) visits and questionnaires (e.g., due to language barriers or living far from the study site).
3 Years
17 Years
ALL
No
Sponsors
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SNF Swiss National Foundation
UNKNOWN
Swiss Clinical Trial Organisation
UNKNOWN
SwissPedNet
UNKNOWN
Christoph Berger
OTHER
Responsible Party
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Christoph Berger
Prof. Dr. med.
Principal Investigators
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Christoph Berger, Prof. Dr. med.
Role: STUDY_CHAIR
University Children's Hospital, Zurich
Locations
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Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, Switzerland
University of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, Switzerland
University Children's Hospital Bern, Switzerland
Bern, Canton of Bern, Switzerland
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, Switzerland
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, Switzerland
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, Switzerland
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, Switzerland
University Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
Bellinzona, Canton Ticino, Switzerland
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
Chur, Kanton Graubünden, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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207286
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2023-01295
Identifier Type: -
Identifier Source: org_study_id
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