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

Conditions

• Community Acquired Pneumonia in Children

Eligibility Criteria

Sex

ALL

Age

3 Months - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Ampicillin for Injection — DRUG
  Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
• Ceftriaxone for Injection — DRUG
  Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
• Amoxicillin — DRUG
  Amoxicillin 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 — DRUG
  Ampicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
• Amoxicillin-clavulanate — DRUG
  Amoxicillin-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 — DRUG
  Clindamycin 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 — DRUG
  Cefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.
• Levofloxacin — DRUG
  Levofloxacin 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.

Study Details

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.

Key Dates

Start date

Aug 22, 2024

Status verified

Feb 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

236 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Short course antibiotic duration
  The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined.
• Active Comparator: Standard of care antibiotic duration
  Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined.

Primary Outcome Measure

Treatment failure rate [ Time Frame: 14 days from the first dose antibiotics ]

Central Contacts

• Michelle Mitchell, MD
  414-337-7070
  [email protected]
• Khaled AL zubaidi, MD
  414-337-7070
  [email protected]

Locations (1)

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