Antibiotic Duration for Infections in Children
(TRIAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a 5-day course of antibiotics is as effective as a 10-day course for children with infections such as pneumonia, skin infections, or urinary tract infections. Researchers seek to identify which duration aids recovery while minimizing side effects. Participants will be randomly assigned to receive either 5 or 10 days of antibiotics, with some taking a placebo (a pill without medicine) after the initial 5 days. The trial seeks children hospitalized with these infections who are taking home antibiotics according to specific guidelines after discharge. As a Phase 4 trial, this research involves an FDA-approved treatment and helps assess its benefits for more patients.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that children discharged with more than one systemic antibiotic prescription are excluded, which might suggest that taking multiple antibiotics could be a concern. It's best to discuss your current medications with the trial team to get a clear answer.
What is the safety track record for these treatments?
Research has shown that a 5-day course of antibiotics is often safe and effective for children with infections like pneumonia and skin infections. Studies have found that these short courses work just as well as longer ones. For example, one study found that children taking a 5-day course for pneumonia did not experience more problems than those on longer treatments. Another study demonstrated that shorter treatments had more benefits and fewer side effects.
In general, children handle shorter antibiotic courses well, experiencing fewer negative side effects, such as stomach issues or allergic reactions. Overall, the evidence supports that 5-day antibiotic treatments are both safe and effective for children with certain infections.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about this trial because it explores the optimal duration of antibiotic treatment for infections in children. Unlike the standard approach where antibiotics might be prescribed for a set period regardless of the specific infection, this trial investigates whether a shorter 5-day course is just as effective as the traditional 10-day course. This could lead to fewer side effects, reduced antibiotic resistance, and a more personalized treatment plan for young patients. By potentially shortening the duration of antibiotic use, the trial aims to improve patient outcomes and promote better antibiotic stewardship.
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
Citations
The Association of Antibiotic Duration With Successful ...
A short course of antibiotic therapy (approximately 5 days) does not increase the odds of 30-day treatment failure compared with longer courses for hospitalized ...
Short-Course Antimicrobial Therapy for Pediatric ...
Results of this study suggest that short-course therapy for pediatric community-acquired pneumonia not requiring hospitalization offers more benefit than harm.
3.
publications.aap.org
publications.aap.org/pediatrics/article/153/2/e2023063691/196375/Improving-Short-Course-Treatment-of-PediatricImproving Short Course Treatment of Pediatric Infections
Short courses of antibiotic treatment are effective for pediatric community-acquired pneumonia (CAP) and skin and soft tissue infections (SSTI).
Take 5 Campaign: Effects of an Intervention to Promote Five ...
We implemented an intervention to promote 5-day durations of antibiotic therapy for common infections in urgent care. The objectives of this study were to ...
Antibiotic Use for Common Infections in Pediatric ...
The median duration of “bad or worse” symptoms were five days for amoxicillin versus six days for placebo. There was also no significant ...
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