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OsteomyelitisPhase 4CHILD@HOME_BJINCT04563325

Oral-only Antibiotics for Bone and Joint Infections in Children

A Phase 4 study testing Oral co-amoxiclav or oral dicloxacillin only and IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin in people with Osteomyelitis and Septic Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. The primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). Children will be randomized 1:1. Read more about this study

Who is it for?
Ages 3 months to 17 years
Conditions the study is for
Osteomyelitis, Septic Arthritis, Bone Infection
What is being tested?
Oral co-amoxiclav or oral dicloxacillin only and IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteDenmark
Study dates
15 Sep 2020to 5 Aug 2024
Phase
Phase 4
Are there results?
None posted in the registry

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

Who may be able to join

  • Children aged 3 months to 18 years with antibiotic treatment of uncomplicated bone or joint infection.

Who cannot join

  • Severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing fasciitis, requiring IV antibiotics in the opinion of the treating clinician.
  • Complicated bone or joint infection, e.g. prosthetic material, infection secondary to or complicated by trauma, severe pyomyositis or other substantial soft tissue infections.
  • Expected need of major surgery within the first 24 hours of treatment, e.g. drilling, debridement, fenestration, surgical drainage, synovectomy. Minor surgery as diagnostic surgical bone biopsy or diagnostic joint fluid aspiration including lavage is not a criterion for exclusion.
  • Significant co-morbidities that might influence the choice of treatment or the course of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell anemia.
  • Previous bone or joint infection.
  • Antibiotic therapy for more than 24 hours before inclusion.
  • Documented pathogen with limited treatment options that do not permit randomization, e.g. the pathogen is only sensitive to intravenous antibiotics.
  • Prior enrolment in the trial

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Official title: Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial

A nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. The primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). Children will be randomized 1:1. The total treatment duration is identical in both groups. The study is open label with blinding of the primary endpoint assessor.

Being tested
Oral co-amoxiclav or oral dicloxacillin only, IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin
Medical subject headings
Osteomyelitis, Arthritis, Infectious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral co-amoxiclav or oral dicloxacillin onlyDrug

    High dose oral treatment followed by standard dose oral treatment

  • IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillinDrug

    IV treatment followed by standard dose oral treatment

Study groups in NCT04563325
Study groupRoleWhat they receive
ExperimentalActive comparator< 5 years: High-dose oral co-amoxiclav (1:8) 33 mg amoxicillin/kg/dose (max. 1 g) three-times daily (TDS) until clinical and paraclinical improvement (min. 3 days) followed by oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis). =/> 5 years: High-dose oral dicloxacillin 50 mg/kg/dose (max. 2 g) four-times daily (QID) until clinical and paraclinical improvement (min. 3 days) followed by oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis). Treatment will be adjusted according to microbiological findings.
Receives: Drug: Oral co-amoxiclav or oral dicloxacillin only
StandardActive comparatorIV ceftriaxon 100 mg/kg/dose (max. 4 g) once daily (QD) (all ages) until clinical and paraclinical improvement (min. 3 days) followed by: < 5 years: Oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis). >/= 5 years: Oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis). Treatment will be adjusted according to microbiological findings.
Receives: Drug: IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sequelae at 6 months

    Proportion of children with sequelae 6 months after initiation of treatment defined as abnormal mobility or function of the affected joint/bone. Evaluated by blinded clinical examination by a qualified pediatrician and/or pediatric orthopedic surgeon.

    Measured: 6 months

Secondary outcomes (2)

  1. Non-acute treatment failure.

    Proportion of children with change of antibiotic therapy due to non-acute treatment failure. This will be evaluated by two pediatric specialists and is suggested by e.g. 1) temperature above 38,5 after more than 72 hours of antibiotic therapy, 2) increasing CRP ( C-reactive protein) after more than 96 hours of antibiotic therapy and 3) no improvement in mobility or pain after 120 hours of antibiotic therapy.

    Measured: 28 days

  2. Recurrent infection

    Proportion of children with recurrence of symptoms and signs (same anatomical location) after completion of antibiotic treatment requiring further antibiotic administration

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start15 Sep 2020
  3. Primary completion1 Jan 2024
  4. Study completion5 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04563325
Sponsor's protocol ID
H-20009117
Acronym
CHILD@HOME_BJI
Status last verified
Apr 2025
First submitted
13 Sep 2020
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study protocol and statistical analysis plan will be shared. The exact plan for sharing Individual Participant Data (IPD) is being prepared.

Publications

  • Nielsen AB, Holm M, Lindhard MS, Glenthoj JP, Borch L, Hartling U, Schmidt LS, Rytter MJH, Rasmussen AH, Damkjaer M, Lemvik G, Petersen JJH, Sondergaard MJ, Thaarup J, Kristensen K, Jensen LH, Hansen LH, Lawaetz MC, Gottliebsen M, Horsager TH, Zaharov T, Hoffmann TU, Nygaard T, Justesen US, Stensballe LG, Vissing NH, Blanche P, Schmiegelow K, Nygaard U. Oral versus intravenous empirical antibiotics in children and adolescents with uncomplicated bone and joint infections: a nationwide, randomised, controlled, non-inferiority trial in Denmark. Lancet Child Adolesc Health. 2024 Sep;8(9):625-635. doi: 10.1016/S2352-4642(24)00133-0. Epub 2024 Jul 15.

    PubMed 39025092

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral co-amoxiclav or oral dicloxacillin only and IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin in people with Osteomyelitis 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?

The sponsor lists 1 inclusion and 8 exclusion criteria. 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: finished, as of the sponsor's last update on 13 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sequelae at 6 months (time frame: 6 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 NCT04563325, which also lists 2 linked publications.

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 13 Apr 2025.

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