Could shorter antibiotic courses be better for hospitalized kids?
NCT ID NCT07322146
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to find out if 5 days of antibiotics works as well as 10 days for children hospitalized with pneumonia, skin infections, or urinary tract infections. About 1,200 children will be randomly assigned to either a 5-day or 10-day course, with some receiving a placebo after day 5. The goal is to balance recovery with fewer side effects and less burden on families.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 days to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: We will include children and adolescents ages 60 days to 17 years and 10 months admitted to the hospital medicine service with a primary diagnosis of PNA, SSTI, or UTI receiving an antibiotic agent that is concordant with any microbiologic results and guideline-concordant. Children are eligible if they are prescribed a post-discharge antibiotic for home that is within our trial formulary. For PNA, children must have radiographic evidence of pneumonia as read by a radiologist, and clinical diagnosis of pneumonia, and clinician prescription of guideline-concordant antibiotics for pneumonia. For SSTI, we will include children with cellulitis alone or cellulitis with abscess that was either drained or deemed too small for drainage. For UTI, children must meet guideline-specified diagnostic criteria. Exclusion Criteria: We will exclude any patients who live independently (without a parent or guardian in the home), including those in county or state custody. We will exclude patients who previously enrolled (i.e., consented and randomized) in the study. We will exclude patients who are not discharging home from hospital medicine service. For all conditions, we will exclude children who require inpatient antibiotics longer than 4 days, as guidelines indicate that a child should be clinically improving to be a candidate for short duration treatment strategy. We will also exclude children discharged with \>1 systemic antibiotic prescription, as this may indicate greater severity of infection or greater diagnostic uncertainty. Other exclusion criteria are also all aligned with guidelines, which exclude children that may require longer duration antibiotics or have higher risk of infections with resistant or atypical organisms, including exclusion of patients requiring \>24 hours in intensive care, patients with immunodeficiency, patients who have been hospitalized in the preceding 30 days before the index hospitalization, patients who are admitted after completing more than 48 hours of outpatient antibiotics to treat the current infection, known pregnant patients, anyone who has an allergy to any of the components of the placebo, and anyone with clear alternate diagnosis, need for treatment of a concomitant diagnosis requiring antibiotics, or uncertainty regarding the qualifying diagnosis (PNA, SSTI, UTI). For pneumonia, we will exclude children with a parapneumonic effusion larger than "trace" or "small" (based on radiologist impression), tracheostomy, high intensity neurologic impairment, cystic fibrosis, sickle cell disease, chronic respiratory failure, or received 3 or more doses of azithromycin. For SSTI, we will exclude children with surgical site infections, cellulitis around a medical device, bone or joint infections, infectious myositis or pyomyositis, implanted hardware or other deep infections, have concomitant HSV, significant chronic dermatologic conditions other than eczema, or pre-septal or orbital cellulitis. Dental abscess without overlying facial cellulitis will also be excluded. We will exclude those discharged from the hospital with a drain in place. However, any abscess at the skin would qualify even if it is drained by a subspecialist, unless it connects with an internal cavity. For UTI, we will exclude children with major genitourinary anomalies, high-grade vesicoureteral reflux, history of urologic surgery other than circumcision, indwelling urinary catheters, need for regular intermittent catheterization, or current renal abscess.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
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Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
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Children's of Alabama
Birmingham, Alabama, 35233, United States
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Cincinnati Children's Hospital Medical Center Liberty Campus
Cincinnati, Ohio, 45044, United States
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Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio, 45229, United States
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Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Primary Children's Hospital
Lehi, Utah, 84043, United States
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Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
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Other studies related to the condition(s) this trial covers.
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