NCT06494072 · Medical College of Wisconsin
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
What this study is about
The goal of this open label, randomly assigned, 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.
View original scientific description
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.
Interventions
DRUG
Ampicillin for Injection
Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
DRUG
Ceftriaxone for Injection
Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
DRUG
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.
DRUG
Ampicillin / Sulbactam Injection
Ampicillin/Sulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.
DRUG
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.
DRUG
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.
DRUG
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.
DRUG
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 measures
Treatment failure rate
Time frame: 14 days from the first dose antibiotics
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (ALL of the following must be met):
- 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).
Exclusion criteria
- (presence of ANY of the following will exclude a potential participant):
- 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
- Inability to adhere to follow up
Where
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 2, 2026 · Source of record for eligibility and locations