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Initial Oral Antibiotics for Bone and Joint Infections in Children

ConditionsOsteomyelitis AcuteSeptic ArthritisBone InfectionJoint InfectionBone and Joint Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Severe illness or sepsis

Rapid symptom progression

Pronounced symptoms, including severe pain

Pronounced soft tissue involvement

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Children and adolescents with bone and joint infections treated with initial oral antibiotics1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Suspicion of treatment failure within 28 days

Change of antibiotic therapy due to suspicion of treatment treatment failure or slow recovery, such as persistent fever for more than 3 days, iincrease in C-reactive protein after 4 days, or absence of clinical improvement within 5 days of treatment initiation.

Time frame
28 days after initiation of treatment
2

Full recovery after initiation of treatment

Full recovery is defined as absence of clinical features of the affected bone or joint. Assessment made by a pediatrician or orthopedic surgeon.

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

Recurrent infection within 6 months

Recurrence of symptoms and signs requiring readministration of antibiotics after initial recovery and cessation of antibiotic treatment.

Time frame
6 months after the end of treatment
4

Clinical sequelae at 12 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 12 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.

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

Other outcomes

1

Safety outcome 1: Surgical intervention

Surgical intervention during antibiotic treatment excluding diagnostic interventions, such as diagnostic bone biopsy or diagnostic joint aspiration with or without lavage.

Time frame
28 days after initiation of treatment
2

Safety outcome 2: Severe complications during antibiotic treatment

Severe complications during antibiotic treatment, e.g. need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis.

Time frame
28 days after initiation of treatment

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

RigshospitaletRecruiting2100, Copenhagen ØDenmarkDenmark

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Innovation Fund Denmark

Collaborator

Source ClinicalTrials.gov
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