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Antibiotics or sugar pill? new study questions need for drugs in Kids' pneumonia

NCT ID NCT06325293

Symptom relief Sponsor: Christoph Berger Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether children with pneumonia caused by Mycoplasma bacteria need antibiotics to get better. About 376 children aged 3-17 will receive either a placebo (inactive pill) or a common antibiotic. Researchers will track how long symptoms like fever and fast breathing last, and whether any children need extra hospital care. The goal is to see if antibiotics are truly necessary for recovery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 376 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia Mycoplasma pneumoniae pneumonia pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Community acquired pneumonia in children Mycoplasma pneumoniae Mycoplasma pneumoniae pneumonia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital Aarau, Switzerland

    ACTIVE_NOT_RECRUITING

    Aarau, Canton of Aargau, 5001, Switzerland

  • Children's Hospital of Central Switzerland, Switzerland

    RECRUITING

    Lucerne, Canton of Lucerne, 6000, Switzerland

  • Children's Hospital of Eastern Switzerland St. Gallen

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, 9006, Switzerland

  • Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland

    NOT_YET_RECRUITING

    Geneva, Canton of Geneva, 1205, Switzerland

  • Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland

    RECRUITING

    Chur, Kanton Graubünden, 7000, Switzerland

  • Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland

    RECRUITING

    Winterthur, Canton of Zurich, 8401, Switzerland

  • Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland

    NOT_YET_RECRUITING

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Department of Pediatrics, Fribourg Hospital, Switzerland

    NOT_YET_RECRUITING

    Fribourg, Canton of Fribourg, 1708, Switzerland

  • Department of Pediatrics, Triemli Hospital Zurich, Switzerland

    NOT_YET_RECRUITING

    Zurich, Canton of Zurich, 8063, Switzerland

  • Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland

    NOT_YET_RECRUITING

    Bellinzona, Canton Ticino, 6500, Switzerland

  • University Children's Hospital Bern, Switzerland

    RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • University Children's Hospital Zurich, Switzerland

    RECRUITING

    Zurich, Canton of Zurich, 8032, Switzerland

  • University of Basel Children's Hospital, Switzerland

    RECRUITING

    Basel, Canton of Basel-City, 4056, Switzerland

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