Comparing a placebo to an antibiotic for pneumonia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of macrolide antibiotics compared to a placebo in treating community-acquired pneumonia caused by Mycoplasma pneumoniae in children aged 3-17 years. Participants will be randomly assigned to receive either the antibiotic azithromycin or a placebo for five days, and their symptoms and vital signs will be monitored until recovery. The study seeks to determine whether antibiotic treatment is necessary for this specific type of pneumonia, addressing concerns about antibiotic resistance and the appropriate use of antibiotics in pediatric care.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Basel Children's Hospital, Switzerland
  Basel, Canton of Basel-City, Switzerland Recruiting
• University Children's Hospital Bern, Switzerland
  Bern, Canton of Bern, Switzerland Recruiting
• Children's Hospital of Central Switzerland, Switzerland
  Lucerne, Canton of Lucerne, Switzerland Recruiting
• Children's Hospital of Eastern Switzerland St. Gallen
  Sankt Gallen, Canton of St. Gallen, Switzerland Recruiting
• Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
  Winterthur, Canton of Zurich, Switzerland Recruiting
• University Children's Hospital Zurich, Switzerland
  Zurich, Canton of Zurich, Switzerland Recruiting

Study contacts

• Study coordinator: Patrick M Meyer Sauteur, PD Dr. Dr. med.
• Email: patrick.meyersauteur@kispi.uzh.ch
• Phone: 0041 44 266 78 96

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing 5-day versus standard antibiotic treatment for pneumonia in children

  This study is testing if a shorter 5-day course of antibiotics is just as effective as the usual 7-14 day treatment for pneumonia in kids aged 3 months to 18 years.

  Recruiting Phase 4 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT06494072

• Observing antibiotic use in children with pneumonia

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• How frailty affects outcomes in older people with pneumonia in the ER

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  Recruiting Ege University · Izmir, Bornova · NCT07442656

• Fever clinic tracking of acute respiratory infections

  This project follows adults who come to a fever clinic with respiratory infections to see how their symptoms, test results, and outcomes change over time.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07278700

• Azithromycin versus doxycycline as atypical coverage for adults hospitalized with community-acquired pneumonia on a beta-lactam

  This trial will test whether adding azithromycin or doxycycline to a beta-lactam works better and is safer for adults hospitalized with community-acquired pneumonia.

  Recruiting Phase 4 Mayo Clinic · Scottsdale, Arizona and 4 other locations · NCT07164131

• Noninvasive breathing support for severe community-acquired pneumonia

  This trial tests whether high-velocity nasal insufflation (HVNI) or standard noninvasive ventilation (NIV) better helps adults with community-acquired pneumonia and low oxygen levels avoid intubation or death within 48 hours.

  Recruiting Assiut University · Asyut, Assuit · NCT06996834

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.