NCT06494072 Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 236 participants in total. It began in 2024-08-22 with a primary completion date of 2028-05.

Brief Summary

The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia. The main questions it aims to answer are: * Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children? * Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia? Participants will * be randomly assigned to either receive 5 total days or a total duration decided by the treating physician * receive a brief follow up questionnaire regarding clinical symptoms, follow up care/antibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics Researchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.

Eligibility Criteria

Inclusion Criteria (ALL of the following must be met): 1. Children aged 3 months to \<18 years old 2. Hospitalized in either the acute care or the pediatric intensive care units 3. Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician) 4. Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates) 5. Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen/ventilatory support and temperature remaining \< 38 Celsius). Exclusion Criteria (presence of ANY of the following will exclude a potential participant): 1. Hemodynamic instability at any point during hospitalization that required inotropic support 2. Requirement of respiratory support \> 72 hours 3. Presence of a parapneumonic effusion \>10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging 4. Need for chest tube placement 5. Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days 6. Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid) 7. Antibiotic course started \>72 hours after admission 8. Antibiotics used for \> 24 hours within the 2 weeks prior to admission 9. Chronic respiratory illness other than asthma or reactive airway disease 10. Immunocompromised patient (primary or secondary) 11. Primary physician refusal 12. Parent refusal 13. Non-English speakers 14. Pregnant or lactating female 15. Participant will become ≥ 18 years old at or before the time of day 14 follow up 16. Inability to adhere to follow up

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