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Compares treatment options for Community Acquired Pneumonia in Children
Official title A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
ClinicalTrials.gov ID: NCT06325293
What this study is testing
What is Azithromycin Pfizer®?
Azithromycin Pfizer® is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for community acquired pneumonia in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Underlying comorbidities: Cystic fibrosis or other chronic lung disorders (excluding asthma), primary or secondary immunodeficiency, sickle-cell...
- History of recurrent pneumonia (two or more episodes) or severe pneumonia (ICU admission or complications of CAP such as lung abscess, effusion, and...
- Antibiotic treatment against Mp within the previous 7 days, including macrolides, tetracyclines, or fluoroquinolones.
See the full eligibility 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:
- 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. Additional 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 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Aarau, Canton of Aargau, Switzerland
- Basel, Canton of Basel-City, Switzerland
- Bern, Canton of Bern, Switzerland
- Fribourg, Canton of Fribourg, Switzerland
- Geneva, Canton of Geneva, Switzerland
- Lucerne, Canton of Lucerne, Switzerland
- Sankt Gallen, Canton of St. Gallen, Switzerland
- Lausanne, Canton of Vaud, Switzerland
- Winterthur, Canton of Zurich, Switzerland
- Zurich, Canton of Zurich, Switzerland
- Bellinzona, Canton Ticino, Switzerland
- Chur, Kanton Graubünden, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarau, Canton of Aargau, Switzerland; Basel, Canton of Basel-City, Switzerland; Bern, Canton of Bern, Switzerland; Fribourg, Canton of Fribourg, Switzerland; Geneva, Canton of Geneva, Switzerland; Lucerne, Canton of Lucerne, Switzerland and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.