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Initial Oral Antibiotics for Bone and Joint Infections in Children

NCT06827496 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Oral antibiotic treatment

Initial antibiotics: Below 5 years: High-dose amoxicillin-clavulanate (8:1 ratio; 100/12.5 mg/kg/day in 3 doses) until clinical improvement and decrease in CRP, followed by dose reduction (4:1 ratio) to 50/12.5 mg/kg/day in 3 doses). 5 years and above: High-dose anti-staphylococcal penicillin (200 mg/kg/day in 4 doses) until clinical improvement and decrease in CRP, with dose reduction (100 mg/kg/day in 4 doses) after clinical improvement Treatment duration of follow-up therapy (after initial high-dose antibiotics): One week for uncomplicated joint infections, three weeks for bone infections, and four weeks for spondylodiscitis

Sponsors & Collaborators

  • Innovation Fund Denmark

    collaborator INDIV

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil · Copenhagen University Hospital, Rigshospitalet, Denmark

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2026-11-15
Completion
2027-05-31

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06827496 on ClinicalTrials.gov