Comparing 5-day versus standard antibiotic treatment 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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

• Comparing a placebo to an antibiotic for pneumonia in children

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• Fever clinic tracking of acute respiratory infections

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• 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.