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

NCT06494072 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PRO00046965
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community Acquired Pneumonia in Children

Keywords

inpatient; pediatric; hospitalized; community acquired pneumonia.; antibiotic duration

Outcome Measures

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.

  14 days from the first dose antibiotics

Secondary Outcomes (1)

• Adverse drug event rate

  14 days from the first dose antibiotics

Study Arms (2)

Short course antibiotic duration

EXPERIMENTAL

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.

Drug: Ampicillin for Injection; Drug: Ceftriaxone for Injection; Drug: Amoxicillin; Drug: Ampicillin / Sulbactam Injection; Drug: Amoxicillin-clavulanate; Drug: Clindamycin; Drug: Cefprozil; Drug: Levofloxacin

Standard of care antibiotic duration

ACTIVE COMPARATOR

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.

Drug: Ampicillin for Injection; Drug: Ceftriaxone for Injection; Drug: Amoxicillin; Drug: Ampicillin / Sulbactam Injection; Drug: Amoxicillin-clavulanate; Drug: Clindamycin; Drug: Cefprozil; Drug: Levofloxacin

Interventions

Ampicillin for Injection DRUG

Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

Short course antibiotic duration; Standard of care antibiotic duration

Ceftriaxone for Injection DRUG

Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

Also known as: Rocephin

Short course antibiotic duration; Standard of care antibiotic duration

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.

Short course antibiotic duration; Standard of care antibiotic duration

Ampicillin / Sulbactam Injection DRUG

Ampicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.

Also known as: Unasyn

Short course antibiotic duration; Standard of care antibiotic duration

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.

Also known as: Augmentin

Short course antibiotic duration; Standard of care antibiotic duration

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.

Also known as: Cleocin

Short course antibiotic duration; Standard of care antibiotic duration

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.

Also known as: Cefzil

Short course antibiotic duration; Standard of care antibiotic duration

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.

Also known as: Levaquin

Short course antibiotic duration; Standard of care antibiotic duration

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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
• Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
• Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)
• Antibiotic course started \>72 hours after admission
• Antibiotics used for \> 24 hours within the 2 weeks prior to admission
• Chronic respiratory illness other than asthma or reactive airway disease
• Immunocompromised patient (primary or secondary)
• Primary physician refusal
• Parent refusal
• Non-English speakers
• Pregnant or lactating female
• Participant will become ≥ 18 years old at or before the time of day 14 follow up

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Childrens Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Ampicillin; Injections; Ceftriaxone; Amoxicillin; sultamicillin; Amoxicillin-Potassium Clavulanate Combination; Clindamycin; Cefprozil; Levofloxacin

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Cefotaxime; Cephacetrile; Cephalosporins; Thiazines; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Michelle Mitchell

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Mitchell, MD

CONTACT

414-337-7070; mimitchell@mcw.edu

Khaled AL zubaidi, MD

CONTACT

414-337-7070; kalzubaidi@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Infectious Diseases

Model Details: Comparison of short duration (5 days) versus a standard of care duration of antibiotics on the effective treatment of children hospitalized for uncomplicated community acquired pneumonia.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)