Actively Recruiting
Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia a Non-inferiority, Randomized Controlled Trial.
Led by Medical College of Wisconsin · Updated on 2026-03-02
236
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a shorter 5-day antibiotic course is as effective as the standard longer course usually 7 to 14 days for treating uncomplicated community acquired pneumonia in hospitalized children aged 3 months to 18 years. This open label, randomized, non-inferiority trial aims to see if the shorter treatment works as well and causes fewer side effects compared to the standard antibiotic duration. The study is sponsored by the Medical College of Wisconsin and involves 150 participants. Participants will be randomly assigned to one of two groups one receiving a total 5-day antibiotic course, and the other receiving the standard antibiotic duration as decided by their treating physician. Antibiotic choices include intravenous and oral options commonly used in pneumonia treatment, such as ampicillin, ceftriaxone, amoxicillin, and others. The course includes days in the hospital and after discharge, with all other medical care guided by the primary doctor. Parents or guardians will be contacted via text or email on day 5 and day 14 after starting antibiotics to complete questionnaires about symptoms, side effects, and any additional care or antibiotics needed. Researchers will monitor treatment failure rates within 14 days, defined by the need for more antibiotics, emergency visits, or hospital readmission. They will also track adverse drug events like allergic reactions or stomach symptoms. The study lasts until 14 days after starting antibiotics, with the goal to compare outcomes between the two treatment durations.
CONDITIONS
Brief Title
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 months to under 18 years old
- Hospitalized in acute care or pediatric intensive care units
- Clinically diagnosed with uncomplicated bacterial community acquired pneumonia
- Radiological signs of pneumonia such as consolidation or infiltrates
- Achieved clinical stability within 72 hours from first antibiotic dose (off oxygen/ventilatory support, temperature under 38 Celsius)
You will not qualify if you...
- Hemodynamic instability requiring inotropic support during hospitalization
- Respiratory support needed for more than 72 hours
- Parapneumonic effusion larger than 10 mm on x-ray or more than one quarter of hemithorax opacified
- Need for chest tube placement
- Infection outside the lungs except otitis media if treatment is 5 days or less
- Pneumonia caused by known staphylococcus aureus infection
- Antibiotic treatment started more than 72 hours after admission
- Antibiotics used for more than 24 hours within two weeks prior to admission
- Chronic respiratory illness other than asthma or reactive airway disease
- Immunocompromised status (primary or secondary)
- Refusal by primary physician or parent
- Non-English speaking
- Pregnant or lactating females
- Participant will turn 18 years old on or before the day 14 follow-up
- Inability to adhere to follow-up requirements
Research Team
M
Michelle Mitchell, MD
K
Khaled AL zubaidi, MD
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