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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ Children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections treated with initial oral antibiotics.

⁃ According to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include:

• Severe illness or sepsis

• Rapid symptom progression

• Pronounced symptoms, including severe pain

• Pronounced soft tissue involvement

• Foreign material or post-surgical infection

• Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA

• Severe comorbidity, including immunodeficiency

⁃ Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included

Locations
Other Locations
Denmark
Rigshospitalet
RECRUITING
Copenhagen Ø
Contact Information
Primary
Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil
Ulrikka.Nygaard@regionh.dk
+45 35459761
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2027-05
Participants
Target number of participants: 100
Treatments
Children and adolescents with bone and joint infections treated with initial oral antibiotics
Patients with uncomplicated bone and joint infections treated with initial oral antibiotics.~According to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include:~1. Severe illness or sepsis~2. Rapid symptom progression~3. Pronounced symptoms, including severe pain~4. Pronounced soft tissue involvement~5. Foreign material or post-surgical infection~6. Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA~7. Severe comorbidity, including immunodeficiency~Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Innovation Fund Denmark

This content was sourced from clinicaltrials.gov