Initial Oral Antibiotics for Bone and Joint Infections in Children

NCT06827496 | Recruiting DMC

• 2 other identifiers: P-2029-290176-00020B
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Bone and joint infections; Children; Oral antibiotics; Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• Clinical sequelae at 6 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.

  6 months after end of treatment [4-9 months]

Secondary Outcomes (5)

• Suspicion of treatment failure within 28 days

  28 days after initiation of treatment

• Full recovery after initiation of treatment

  Within 3 months after initiation of treatment (0-4 months)

• Recurrent infection within 6 months

  6 months after the end of treatment

• Clinical sequelae at 12 months

  12 months after the end of treatment [9-16 months]

• Sequelae at 5 years

  5 years after the end of treatment [4-6 years]

Other Outcomes (2)

• Safety outcome 1: Surgical intervention

  28 days after initiation of treatment

• Safety outcome 2: Severe complications during antibiotic treatment

  28 days after initiation of treatment

Study Arms (1)

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

Drug: Oral antibiotic treatment

Interventions

Oral antibiotic treatment DRUG

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

Children and adolescents with bone and joint infections treated with initial oral antibiotics

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 3 months to 17 years with uncomplicated bone and joint infections treated with initial oral antibioticsbetween 15th of November 2024 and 15th of November 2026

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: 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen Ø, 2100, Denmark

RECRUITING

Related Publications (1)

• Bybeck Nielsen A, Borch L, Damkjaer M, Glenthoj JP, Hartling U, Hoffmann TU, Holm M, Helleskov Rasmussen A, Schmidt LS, Schmiegelow K, Stensballe LG, Nygaard U; Local Investigators. Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised open-label non-inferiority trial. BMJ Open. 2023 Jun 1;13(6):e072622. doi: 10.1136/bmjopen-2023-072622.

  PMID: 37263683 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

MeSH Terms

Conditions

Arthritis, Infectious; Osteomyelitis

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Bone Diseases, Infectious; Bone Diseases

Study Officials

• Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil

  Copenhagen University Hospital, Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil

CONTACT

+45 35459761; Ulrikka.Nygaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Professor, Consultant, PhD, MD, MPhil

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

DK (1)