Trial of Reducing Inpatient Antibiotic Durations in Children
NCT ID: NCT07322146
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
1200 participants
INTERVENTIONAL
2026-02-28
2031-08-31
Brief Summary
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Our three caregiver co-investigators, other parents of hospitalized children, doctors, other care providers, and researchers, all believe that additional study is needed to determine the best length of antibiotic treatment that weighs both the benefits and harms of antibiotics.
The goal of our study is to understand if 5 total days of antibiotic treatment compared to 10 total days of antibiotic treatment is better for children who have been in the hospital for pneumonia, SSTI, or UTI. We will study this question through a randomized control trial. In other words, half of the children will receive 5-days of antibiotics and the other half will receive 10-days of antibiotics. Children in this study (and their caregivers) will not know how many days of antibiotics they will receive to cure their infection because some children will take a placebo (or a pill without antibiotics in it). Only the pharmacy will know if a child is getting antibiotic or placebo (for days 6-10 of treatment).
During the first phase of the trial (feasibility phase), 4 hospitals will enroll children in the study. We plan on enrolling 50 patients during this phase. We are starting with just 4 hospitals, so our study team can create and update our study plans if needed. We will closely review information about how many patients and families agree to participate, and if they have any trouble completing any part of the study. We will also interview families to understand the choice to participate in the study, the choice not to participate in the study, and what it is like to be in the study.
During the second study phase, we will enroll 1150 more patients across all 11 hospitals. Families will complete short, daily surveys until the 15th day after they started antibiotics, then a larger survey at day 15, at day 20, and at day 30. These surveys will ask about the child's symptoms and recovery from their illness, how the antibiotics are making them feel, and if they had to go back to their doctor, emergency room, or hospital. The answers to these questions will be combined to measure how well the child did, balancing feeling better and having bad effects from the antibiotics.
We will use mathematical tests to determine which antibiotic duration is better for treating these illnesses. We will complete other mathematical tests to see if all children should receive the same length of antibiotics or if certain children should be prescribed shorter courses and others longer courses.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5-day duration treatment strategy
Participants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a placebo, for days 6-10 of therapy.
Study Drug Placebo
Placebo, medically nonactive drug
10-day duration treatment strategy
Participants will use the antibiotic prescribed by thier hospital care team for the first 5 days of antibiotic therapy. They will change to study medication, a continuation of that antibiotic, for days 6-10 of therapy.
No interventions assigned to this group
Interventions
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Study Drug Placebo
Placebo, medically nonactive drug
Eligibility Criteria
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Inclusion Criteria
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
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.
60 Days
17 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Sunitha V Kaiser, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Children's National Hospital
Washington D.C., District of Columbia, United States
Cincinnati Children's Hospital Medical Center Liberty Campus
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center-Burnet Campus
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carrell Jr Children's Hospital at Vanderbilt University Medical Center
Nashville, Tennessee, United States
Primary Children's Hospital
Lehi, Utah, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-45723
Identifier Type: -
Identifier Source: org_study_id
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