Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark

NCT06827496 RECRUITING

Initial oral antibiotic treatment for children and adolescents with uncomplicated bone and joint infections (BJI) has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT). The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. This nationwide, prospective, multicenter, real-world cohort study aims to compare the effectiveness and safety of initial oral antibiotic treatment for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.

Details

Lead sponsor	Rigshospitalet, Denmark
Status	RECRUITING
Enrolment	100
Start date	2024-11-15
Completion	2027-05

Conditions

• Osteomyelitis Acute
• Septic Arthritis
• Bone Infection
• Joint Infection
• Bone and Joint Infection

Interventions

• Oral antibiotic treatment

Primary outcomes

• Clinical sequelae at 6 months — 6 months after end of treatment [4-9 months]
  Clinical sequelae is defined as any abnormal mobility or function of the affected bone or joint. Clinical sequelae will be evaluated through a structured medical telephone interview at 6 months with a parent or a guardian (or the patient, if adolescent, along with the parent). If the medical interview raises any concerns about abnormal mobility or function of the affected bone or joint, or if the patient is scheduled for a clinical consultation, clinical sequelae will be evaluated by a clinical examination performed by a pediatrician or an orthopedic surgeon.

Countries

Denmark