Recruiting

Antibiotic Duration

Sponsor:

Medical College of Wisconsin

Code:

NCT06494072

Conditions

Community Acquired Pneumonia in Children

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Ampicillin for Injection

Ceftriaxone for Injection

Amoxicillin

Ampicillin / Sulbactam Injection

Amoxicillin-clavulanate

Study Details

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

Study ID

NCT06494072

Start date

Aug 22, 2024

Status verified date

Feb, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria (ALL of the following must be met):

1. Children aged 3 months to <18 years old
2. Hospitalized in either the acute care or the pediatric intensive care units
3. Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)
4. Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)
5. 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).

Exclusion Criteria (presence of ANY of the following will exclude a potential participant):

1. Hemodynamic instability at any point during hospitalization that required inotropic support
2. Requirement of respiratory support > 72 hours
3. Presence of a parapneumonic effusion >10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging
4. Need for chest tube placement
5. Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days
6. Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)
7. Antibiotic course started >72 hours after admission
8. Antibiotics used for > 24 hours within the 2 weeks prior to admission
9. Chronic respiratory illness other than asthma or reactive airway disease
10. Immunocompromised patient (primary or secondary)
11. Primary physician refusal
12. Parent refusal
13. Non-English speakers
14. Pregnant or lactating female
15. Participant will become ≥ 18 years old at or before the time of day 14 follow up
16. Inability to adhere to follow up

Study Design

Enrollment

236 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ampicillin for Injection

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

Ceftriaxone for Injection

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

Amoxicillin

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

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

Amoxicillin-clavulanate

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

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

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michelle Mitchell, MD

414-337-7070mimitchell@mcw.edu

Khaled AL zubaidi, MD

414-337-7070kalzubaidi@mcw.edu

Locations

Childrens Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Michelle Mitchell, MD

4143377070mimitchell@mcw.edu

Principal Investigator:

Michelle Mitchell, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-03-02.