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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ampicillin for Injection
DrugAmpicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
Ceftriaxone for Injection
DrugCeftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
Amoxicillin
DrugAmoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
Ampicillin / Sulbactam Injection
DrugAmpicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
Amoxicillin-clavulanate
DrugAmoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
Clindamycin
DrugClindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.
Cefprozil
DrugCefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
Levofloxacin
DrugLevofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.
Treatment groups
236 Participants
are divided into 2 treatment groupsGroup A: Short course antibiotic durationExperimental treatment 8 interventions
Group B: Standard of care antibiotic durationActive comparator 8 interventions
Trial outcomes
Primary outcomes
1
Treatment failure rate
Treatment failure is defined as the clinical need for additional antibiotic treatment, an emergency department (ED) visit, or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation.
Time frame
14 days from the first dose antibioticsSecondary outcomes
1
Adverse drug event rate
Adverse drug events include allergic reactions, skin rash, abdominal symptoms (such as vomiting, stomach pain, or diarrhea), or other plausible associated complaints described by the parent(s)/guardian.
Time frame
14 days from the first dose antibioticsSponsors and contacts
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Source ClinicalTrials.gov