Antibiotic Duration for Infections in Children
(TRIAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Infections like pneumonia, skin and soft tissue infection (also called SSTI or cellulitis), and urinary tract infections (UTI) are some of the most common reasons children get admitted to the hospital. All three of these conditions require antibiotics for treatment. Although antibiotics are needed to treat the infection and help children feel better, taking them longer than needed can negatively impact children and their families. Negative impacts include things like the burdens of taking more medications and medication side effects. There are guidelines (instructions) from expert medical organizations that suggest the number of days children need antibiotics, but they give a wide range (between 5 and 14 days). Unfortunately, these guidelines are not based on high-quality studies. National data suggests that doctors often choose on the higher end of this range when writing prescriptions for children in the hospital.
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.
Who Is on the Research Team?
Sunitha V Kaiser, MD, MSc
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for children hospitalized with pneumonia, skin and soft tissue infections (cellulitis), or urinary tract infections. They must be eligible to receive either a 5-day or 10-day antibiotic treatment. Specific inclusion and exclusion criteria details are not provided, but typically these would outline the age range, severity of condition, and any other health considerations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Feasibility Phase
Initial phase to enroll 50 patients across 4 hospitals to refine study plans and assess participation challenges
Treatment
Participants receive either 5 or 10 days of antibiotic treatment, with a placebo for days 6-10 in the 5-day group
Follow-up
Families complete daily surveys until day 15, with additional surveys on days 15, 20, and 30 to monitor symptoms and recovery
What Are the Treatments Tested in This Trial?
Interventions
- Study Drug Placebo
Trial Overview
The study is testing whether a shorter course of antibiotics (5 days) is as effective as a longer course (10 days) in treating certain infections in hospitalized children. It's a randomized control trial where half the participants will receive the standard duration of antibiotics while the other half will get a placebo after day five.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
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