Comparing 5-day versus standard antibiotic treatment for pneumonia in children
Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT06494072 on ClinicalTrials.gov |
What this trial studies
This open label, randomized, non-inferiority clinical trial aims to evaluate the effectiveness of a 5-day antibiotic course compared to the standard 7-14 day course for treating uncomplicated community acquired pneumonia in hospitalized children aged 3 months to 18 years. Participants will be randomly assigned to receive either the shorter or standard duration of antibiotics, with follow-up assessments conducted via questionnaire at days 5 and 14 post-treatment. The study seeks to determine if the shorter course is equally effective and results in fewer side effects.
Who should consider this trial
Good fit: Ideal candidates are hospitalized children aged 3 months to less than 18 years with uncomplicated community acquired pneumonia.
Not a fit: Patients with severe pneumonia requiring prolonged respiratory support or those with significant complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter antibiotic treatments for children with pneumonia, reducing side effects and antibiotic resistance.
How similar studies have performed: Previous studies have shown promising results with shorter antibiotic courses for various infections, suggesting potential success for this approach in pediatric pneumonia.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milwaukee, Wisconsin
- Childrens Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Mitchell — Medical College of Wisconsin
- Study coordinator: Michelle Mitchell, MD
- Email: mimitchell@mcw.edu
- Phone: 414-337-7070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.