Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised...

Area of Science:

• Pediatric Infectious Diseases
• Orthopedic Surgery
• Clinical Pharmacology

Background:

• Traditional treatment for pediatric bone and joint infections involves prolonged intravenous antibiotics followed by oral administration.
• Randomized trials evaluating oral-only antibiotic regimens for this patient population are lacking.

Purpose of the Study:

• To assess the non-inferiority of high-dose oral antibiotics compared to standard intravenous-to-oral antibiotic treatment in children with bone and joint infections.
• To evaluate the potential for reducing hospitalizations and intravenous antibiotic utilization.

Main Methods:

• A randomized controlled trial comparing high-dose oral antibiotics with standard intravenous-to-oral therapy in children aged 3 months to 18 years.
• Exclusion of children requiring acute surgery or with severe systemic illness (e.g., septic shock).
• Primary outcome: normal clinical assessment at 6 months post-treatment; secondary outcomes: treatment failure and recurrence.

Main Results:

• The study is designed to demonstrate that oral-only antibiotic therapy is non-inferior to the traditional approach.
• Anticipated minimal risk of treatment failure due to close monitoring and strict exclusion criteria.

Conclusions:

• This trial may establish oral-only antibiotic therapy as a viable and potentially less burdensome treatment option for pediatric bone and joint infections.
• Successful outcomes could lead to significant changes in clinical practice, reducing healthcare costs and improving patient experience.