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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorMedical College of Wisconsin

About this trial

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

Qualifiers

Children aged 3 months to <18 years old

Hospitalized in either the acute care or the pediatric intensive care units

Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)

Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)

Disqualifiers

Hemodynamic instability at any point during hospitalization that required inotropic support

Requirement of respiratory support > 72 hours

Presence of a parapneumonic effusion >10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging

Need for chest tube placement

Trial design

Treatments tested in this trial

  • Ampicillin for Injection
  • Ceftriaxone for Injection
  • Amoxicillin
  • Ampicillin / Sulbactam Injection
  • Amoxicillin-clavulanate
  • Clindamycin
  • Cefprozil
  • Levofloxacin

Treatment groups

236 Participants
are divided into 2 treatment groups

Sponsors and collaborators