A randomized controlled study on the use of antibiotics in children with pneumonia caused by mycoplasma
Summary description of the study
In the MYTHIC Study, we want to find out whether the treatment of pneumonia caused by mycoplasma with antibiotics is really necessary. Pneumonia is caused by bacteria, viruses, or fungi. Antibiotic therapy is only effective against bacteria. Each antibiotic also works only against certain types of bacteria. Mycoplasmas (Mycoplasma pneumoniae) are one of the most common bacterial causes of pneumonia in children. The recommended antibiotics against mycoplasmas are macrolides, which are the second most commonly used antibiotics in children after penicillin antibiotics. However, the effectiveness of macrolides in children with mycoplasma pneumonia is unclear. The excessive use of macrolides has led to a global development of bacterial resistance to these antibiotics. Therefore, it is important to use antibiotics only when absolutely necessary. Based on clear evidence from previous studies, we assume that children receiving macrolides will take the same time to recover from mycoplasma infection as children receiving a placebo. The children will be closely monitored during the study, so participation in the study poses no risk to the children.
(BASEC)
Intervention under investigation
In this study, participants will be randomly assigned to two groups: Group 1 (experimental group) will receive a macrolide antibiotic and Group 2 (control group) will receive a placebo (medication without active ingredient). Neither the participants nor the investigators will know who has been assigned to which group. The idea is to minimize the influence on the results. Through these measures, we can objectively assess whether the placebo is not worse than the antibiotic. The study lasts 28 days and includes 2 additional examinations as well as 3 telephone check-ups.
(BASEC)
Disease under investigation
A bacterial pneumonia is usually treated with antibiotics. Many antibiotics are no longer effective due to the development of bacterial resistance. In this study, we investigate whether the treatment of pneumonia caused by mycoplasmas with antibiotics is really necessary.
(BASEC)
- Children and adolescents aged 3-17 years presenting to the emergency department with pneumonia - Clinical diagnosis of pneumonia AND fever >38°C AND tachypnea (respiratory rate above age-specific reference values) - Positive screening test for mycoplasma infection - Written informed consent (BASEC)
Exclusion criteria
- Known intolerance to azithromycin - Underlying comorbidities: cystic fibrosis or other chronic lung diseases (excluding asthma), primary or secondary immunodeficiency, cardiovascular disease, or severe cerebral palsy or myasthenia gravis - History of recurrent pneumonia (two or more episodes) or severe pneumonia - Antibiotic treatment for mycoplasmas within the last 7 days - Transfer to intensive care directly from the emergency department - Inability to take oral medications - It is unlikely that parents will attend follow-up visits as part of the study and reliably complete questionnaires, e.g., due to language barriers or because they live far from the study site (BASEC)
Trial sites
Aarau, Basel, Bellinzona, Bern, Chur, Freiburg, Geneva, Lausanne, Luzern, St. Gallen, Winterthur, Zurich
(BASEC)
Sponsor
Christoph Berger - University Children's Hospital Zurich
(BASEC)
Contact
Contact Person Switzerland
PD Dr. Dr. med. Patrick M. Meyer Sauteur
+41 44 266 78 96
patrick.meyersauteur@clutterkispi.uzh.chUniversity Children's Hospital Zurich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
14.05.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia - MYTHIC Study (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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