Osteomyelitis AcuteNCT06827496
Initial Oral Antibiotics for Bone and Joint Infections in Children
An observational study of Osteomyelitis Acute and Septic Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Osteomyelitis Acute, Septic Arthritis, Bone Infection
- What is being tested?
- Oral antibiotic treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2024to May 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark
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.
Read the detailed description
Background:
Initial oral antibiotic treatment for children and adolescents with uncomplicated BJI has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT) from Denmark. The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. In Denmark, initial oral antibiotics were allowed in nationwide guidelines for children and adolescents aged 3 months to 17 years with uncomplicated BJI from 2024.
Aim:
We aim to compare the effectiveness and safety of initial oral antibiotics for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.
Study design:
Nationwide, prospective, multicenter, real-world cohort study.
Patients:
100 children and adolescents aged 3 months to 17 years with uncomplicated BJI treated with initial oral antibiotics at one of the 18 Pediatric Departments in Denmark from 2024 to 2026. Uncomplicated BJI is defined by the absence of impaired general condition or signs of sepsis, rapidly progressing or severe symptoms, pronounced soft tissue involvement, prosthetic material, resistant pathogens, and severe comorbidities. Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included.
Control patients are 98 patients who received initial oral antibiotics for uncomplicated BJI as part of a Danish RCT conducted between 2020 and 2023.
Methods:
All children and adolescents treated for BJI will be prospectively enrolled. Designated co-investigators in the 18 Danish pediatric departments will ensure prospective, national inclusion. Follow-up assessments will be conducted after three, six, 12 month. The three-month follow-up will include a clinical examination to ensure full recovery. The six and 12-month follow-up will be conducted via a structured telephone interview and/or a clinical evaluation.
All study data will be securely collected and managed in an online database.
Outcomes:
The primary outcome is sequelae after 6 months, defined as any atypical mobility or function of the affected bone or joint.
Secondary outcomes are suspicion of treatment failure within 28 days, full recovery after initiation of treatment, recurrent infection within 6 months, and sequelae after 12 months and 5 years.
Safety outcomes are surgical intervention and severe complications during antibiotic treatment.
We will calculate the risk difference sequelae between the real-world and RCT cohorts using exact unconditional two-sided 95% confidence interval.
- Conditions
- Osteomyelitis Acute, Septic Arthritis, Bone Infection, Joint Infection, Bone and Joint Infection
- Being tested
- Oral antibiotic treatment
- Keywords
- Bone and joint infections, Children, Oral antibiotics, Osteomyelitis
- Medical subject headings
- Arthritis, Infectious, Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral antibiotic treatmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Oral antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after end of treatment [4-9 months]
Secondary outcomes (5)
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.
Measured: 28 days after initiation of treatment
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.
Measured: Within 3 months after initiation of treatment (0-4 months)
Recurrent infection within 6 months
Recurrence of symptoms and signs requiring readministration of antibiotics after initial recovery and cessation of antibiotic treatment.
Measured: 6 months after the end of treatment
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.
Measured: 12 months after the end of treatment [9-16 months]
Sequelae at 5 years
Sequelae is defined as any abnormal mobility or function of the affected bone or joint.
The child is deemed to have no long-term clinical sequelae if there are no hospital contacts for atypical mobility or function of the affected bone or joint and if he/she is still registered as residing in Denmark (defined as 'lost to follow-up' if no longer residing in Denmark)
Measured: 5 years after the end of treatment [4-6 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start15 Nov 2024
- Primary completion15 Nov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteomyelitis AcuteStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Ulrikka Nygaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil, Study chair, Copenhagen University Hospital, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827496
- Sponsor's protocol ID
- P-2029-29
- Other IDs
- 0176-00020B
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37263683
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark
- ClinicalTrials.gov ID
- NCT06827496
- Acronym / sponsor ID
- P-2029-29
- Conditions
- Osteomyelitis Acute, Septic Arthritis, Bone Infection, Joint Infection, Bone and Joint Infection
- Keywords
- Bone and joint infections, Children, Oral antibiotics, Osteomyelitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Initial oral antibiotic treatment for children and adolescents with uncomplicated BJI has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT) from Denmark. The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. In Denmark, initial oral antibiotics were allowed in nationwide guidelines for children and adolescents aged 3 months to 17 years with uncomplicated BJI from 2024.
Aim:
We aim to compare the effectiveness and safety of initial oral antibiotics for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.
Study design:
Nationwide, prospective, multicenter, real-world cohort study.
Patients:
100 children and adolescents aged 3 months to 17 years with uncomplicated BJI treated with initial oral antibiotics at one of the 18 Pediatric Departments in Denmark from 2024 to 2026. Uncomplicated BJI is defined by the absence of impaired general condition or signs of sepsis, rapidly progressing or severe symptoms, pronounced soft tissue involvement, prosthetic material, resistant pathogens, and severe comorbidities. Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included.
Control patients are 98 patients who received initial oral antibiotics for uncomplicated BJI as part of a Danish RCT conducted between 2020 and 2023.
Methods:
All children and adolescents treated for BJI will be prospectively enrolled. Designated co-investigators in the 18 Danish pediatric departments will ensure prospective, national inclusion. Follow-up assessments will be conducted after three, six, 12 month. The three-month follow-up will include a clinical examination to ensure full recovery. The six and 12-month follow-up will be conducted via a structured telephone interview and/or a clinical evaluation.
All study data will be securely collected and managed in an online database.
Outcomes:
The primary outcome is sequelae after 6 months, defined as any atypical mobility or function of the affected bone or joint.
Secondary outcomes are suspicion of treatment failure within 28 days, full recovery after initiation of treatment, recurrent infection within 6 months, and sequelae after 12 months and 5 years.
Safety outcomes are surgical intervention and severe complications during antibiotic treatment.
We will calculate the risk difference sequelae between the real-world and RCT cohorts using exact unconditional two-sided 95% confidence interval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents with bone and joint infections treated with initial oral antibiotics | – | Drug: Oral antibiotic treatmentPatients 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 |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral antibiotic treatmentInitial 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 | Drug | Children and adolescents with bone and joint infections treated with initial oral antibiotics |
Primary outcome
Clinical sequelae at 6 months
Time frame: 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.
5 secondary outcomes
Suspicion of treatment failure within 28 days
Time frame: 28 days after initiation of treatment
Full recovery after initiation of treatment
Time frame: Within 3 months after initiation of treatment (0-4 months)
Recurrent infection within 6 months
Time frame: 6 months after the end of treatment
Clinical sequelae at 12 months
Time frame: 12 months after the end of treatment [9-16 months]
Sequelae at 5 years
Time frame: 5 years after the end of treatment [4-6 years]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 37263683Bybeck 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.
- Individual participant dataSharing planned: Undecided
Related trials for Osteomyelitis Acute
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil study chair
Copenhagen University Hospital, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis Acute and Septic Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil (+45 35459761, Ulrikka.Nygaard@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical sequelae at 6 months (time frame: 6 months after end of treatment [4-9 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.