Community Acquired Pneumonia in ChildrenMYTHICNCT06325293
A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
A study testing Azithromycin Pfizer® in people with Community Acquired Pneumonia in Children and Mycoplasma Pneumoniae, run by Christoph Berger at 13 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- Azithromycin Pfizer®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 13 sitesSwitzerland
- Study dates
- 28 Jan 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Diagnosis defined as the treating physician's documented diagnosis of CAP; AND
- 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- None.
- Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongation*; myasthenia gravis.
- Co-medication with arrhythmogenic or QT-interval-prolonging drug (www.qtdrugs.org) is no exclusion criteria but will be discussed with the local investigators and/or trial management team (TMT).
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Switzerland13 sites, 12 recruiting
- Active, not recruiting
Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, 5001
- Recruiting
University of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, 4056
Julia A Bielicki, PD Dr. Dr. med., 0041 61 704 12 12, julia.bielicki@ukbb.ch
Julia A Bielicki, PD Dr. Dr. med.
- Not yet recruiting
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
Bellinzona, Canton Ticino, 6500
Lisa Kottanattu, Dr. med., 0041 91 811 91 11, Lisa.Kottanattu@eoc.ch
Lisa Kottanattu, Dr. med.
- Recruiting
University Children's Hospital Bern, Switzerland
Bern, Canton of Bern, 3010
Philipp Agyeman, PD Dr. med., 0041 31 632 21 11, Philipp.Agyeman@insel.ch
Philipp Agyeman, PD Dr. med.
- Recruiting
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
Chur, Kanton Graubünden, 7000
Beate Deubzer, Dr. med., 0041 81 256 61 11, beate.deubzer@ksgr.ch
Beate Deubzer, Dr. med.
- Not yet recruiting
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, 1708
Petra Zimmermann, PD Dr. Dr. med., 0041 26 306 00 00, petra.zimmermann@unifr.ch
Petra Zimmermann, PD Dr. Dr. med.
- Not yet recruiting
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, 1205
Noémie Wagner, Dr. med., 0041 22 372 40 00, Noemie.Wagner@hcuge.ch
Noémie Wagner, Dr. med.
- Not yet recruiting
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, 1011
Ludivine Coulon, Dr. med., 0041 21 314 11 11, Ludivine.Coulon@chuv.ch
Ludivine Coulon, Dr. med.
- Recruiting
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, 6000
Alex Donas, Dr. med., 0041 41 205 31 66, alex.donas@luks.ch
Alex Donas, Dr. med.
- Recruiting
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, 9006
Anita Niederer-Loher, Dr. med., 0041 71 243 71 11, anita.niederer@kispisg.ch
Anita Niederer-Loher, Dr. med.
- Recruiting
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, 8401
Andreas Jung, Dr. med., 0041 52 266 41 44, andreas.jung@ksw.ch
Andreas Jung, Dr. med.
- Recruiting
University Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, 8032
Michelle Seiler, PD Dr. med, 0041 44 266 71 11, Michelle.Seiler@kispi.uzh.ch
Michelle Seiler, PD Dr. med
- Not yet recruiting
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
Zurich, Canton of Zurich, 8063
Maren Tomaske, Prof. Dr. med., 0041 44 416 11 11, Maren.Tomaske@stadtspital.ch
Maren Tomaske, Prof. Dr. med.
About this study
Official title: A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
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.
Read the 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.
- Conditions
- Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia
- Being tested
- Azithromycin Pfizer®, Placebo
- Keywords
- Mycoplasma pneumoniae, community-acquired pneumonia, randomized controlled trial, Investigator Initiated Clinical Trial (IICT), Paediatric pneumonia, children, placebo, macrolides
- Medical subject headings
- Pneumonia, Mycoplasma, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin Pfizer®Drug
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
PlaceboDrug
Control comparator arm: 5 days of placebo
| Study group | Role | What they receive |
|---|---|---|
| IMP arm | Active comparator | 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 Receives: Drug: Azithromycin Pfizer® |
| Placebo arm | Placebo comparator | 5 days of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment assessed up to 28 days.
Secondary outcomes (5)
Overall clinical outcome
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.
Measured: From enrollment until end of treatment at 5 days.
Time (days) to normalization of CAP-related symptoms
Time (days) to normalization of CAP-related symptoms assessed up to 28 days.
Measured: 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
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.
Measured: From enrollment assessed up to 28 days.
Time (days) to return to daily routine
Time (days) to return to daily routine, defined as return to childcare/school/work of patients and their families.
Measured: From enrollment assessed up to 28 days.
Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report
Development of Mp-associated extrapulmonary manifestations within 28 days after randomization based on clinical examination and/or parent report.
Measured: From enrollment assessed up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start28 Jan 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Community Acquired Pneumonia in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christoph Berger
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Clinical Trial Organisation, SwissPedNet
- Responsible party
- Sponsor-investigator, Christoph Berger, University Children's Hospital, Zurich
- Investigators
- Christoph Berger, Prof. Dr. med., Study chair, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325293
- Sponsor's protocol ID
- 2023-01295
- Other IDs
- 207286, 2023
- Acronym
- MYTHIC
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31665253Meyer 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.
PubMed 32034406Meyer 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.
PubMed 31251669Meyer 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.
PubMed 38008103Kutty 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.
PubMed 29788037Williams 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.
PubMed 29084336Biondi 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.
PubMed 24864174Gardiner 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.
PubMed 25566754Meyer 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.
PubMed 39363201
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
- ClinicalTrials.gov ID
- NCT06325293
- Acronym / sponsor ID
- MYTHIC / 2023-01295
- Conditions
- Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia
- Keywords
- Mycoplasma pneumoniae, community-acquired pneumonia, randomized controlled trial, Investigator Initiated Clinical Trial (IICT), Paediatric pneumonia, children, placebo, macrolides
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Christoph BergerUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Clinical Trial Organisation, SwissPedNet
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, multicenter, non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| IMP arm | Active comparator | Drug: 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 |
| Placebo arm | Placebo comparator | Drug: Placebo5 days of placebo |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- None.
- Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongation*; myasthenia gravis.
- Co-medication with arrhythmogenic or QT-interval-prolonging drug (www.qtdrugs.org) is no exclusion criteria but will be discussed with the local investigators and/or trial management team (TMT).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | IMP arm |
| PlaceboControl comparator arm: 5 days of placebo | Drug | Placebo arm |
Primary outcome
Co-primary outcome: days to normalization of all vital signs
Time frame: 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
Time frame: 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.
5 secondary outcomes
Overall clinical outcome
Time frame: From enrollment until end of treatment at 5 days.
Time (days) to normalization of CAP-related symptoms
Time frame: 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
Time frame: From enrollment assessed up to 28 days.
Time (days) to return to daily routine
Time frame: From enrollment assessed up to 28 days.
Incidence of Mp-associated extrapulmonary manifestations development in patients assessed by clinical examination and/or parent report
Time frame: From enrollment assessed up to 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 31665253Meyer 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.
- Background: PubMed 32034406Meyer 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.
- Background: PubMed 31251669Meyer 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.
- Background: PubMed 38008103Meyer 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.
- Background: PubMed 29788037Kutty 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.
- Background: PubMed 29084336Williams 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.
- Background: PubMed 24864174Biondi 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.
- Background: PubMed 25566754Gardiner 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.
- Derived from this study: PubMed 39363201Meyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Berger, Prof. Dr. med. study chair
University Children's Hospital, Zurich
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin Pfizer® in people with Community Acquired Pneumonia in Children and Mycoplasma Pneumoniae, run by Christoph Berger at 13 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick M Meyer Sauteur, PD Dr. Dr. med. (0041 44 266 78 96, patrick.meyersauteur@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary outcome: days to normalization of all vital signs (time frame: From enrollment until normalization of all vital signs for at least 24h assessed up to 28 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325293, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.