A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study

Launched by CHRISTOPH BERGER · Mar 15, 2024

Keywords

ClinConnect Summary

The MYTHIC Study is a clinical trial designed to find out if children with pneumonia caused by a specific germ called Mycoplasma pneumoniae really need antibiotic treatment. In this study, children aged 3 to 17 years who have been diagnosed with community-acquired pneumonia and show symptoms like fever and rapid breathing will be invited to participate. Half of the participants will receive a placebo, which is a look-alike treatment with no active medicine, while the other half will receive an antibiotic called azithromycin. Researchers will track how long the children have symptoms to see if there is a difference between those who received the antibiotic and those who received the placebo.

To be eligible for this study, children must have a positive test for the Mycoplasma pneumoniae germ and must not have certain health issues that could prevent them from taking the antibiotic safely. Parents or guardians will need to give written consent for their child to participate, and children aged 14 and older will also sign a consent form. Participants can expect regular check-ups to monitor their symptoms and health until they recover. This study aims to help doctors understand the best way to treat pneumonia in children caused by this specific germ.

Gender

ALL

Eligibility criteria

• Inclusion criteria for screening phase:
• • 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:
• • 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.
• 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.
• Exclusion criteria:
• Exclusion criteria for screening phase:
• • • None.
• Exclusion criteria for intervention phase:
• • 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.
• • 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).