A Phase 4 interventional study of Oral co-amoxiclav or oral dicloxacillin only and IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin in Osteomyelitis, Septic Arthritis and Bone Infection, sponsored by Copenhagen University Hospital, Rigshospitalet. Completed at 1 site in Denmark. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by Copenhagen University Hospital, Rigshospitalet · Phase 4, Interventional, and Treatment
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's enrollment of 180 is above the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 42 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\< 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.
Drug: Oral co-amoxiclav or oral dicloxacillin only
IV 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.
Drug: IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin
High dose oral treatment followed by standard dose oral treatment
IV treatment followed by standard dose oral treatment
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.
Time frame: 6 months
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.
Time frame: 28 days
Recurrent infection
Proportion of children with recurrence of symptoms and signs (same anatomical location) after completion of antibiotic treatment requiring further antibiotic administration
Time frame: 6 months
Safety Outcome 1: Severe complications during antibiotic treatment.
Proportion of children with severe complications during antibiotic treatment, e.g. need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis.
Time frame: 28 days
Safety Outcome 2: Surgical intervention
Proportion of children with need for surgical intervention during antibiotic treatment. Diagnostic surgical intervention (diagnostic joint aspiration or diagnostic bone biopsy) excluded.
Time frame: 28 days
Safety Outcome 3: Treatment related adverse events
Proportion of children with treatment related adverse events e.g. complications of IV access (infection, need for replacement, extravasation) and drug side effects reported by medical staff or by parents (electronic questionnaire).
Time frame: 3 months
Time to apyrexia from initiation of antibiotic treatment
Time frame: 28 days
Mobility and pain
Level of mobility and pain assessed by daily grading of symptoms by medical staff as well as daily standardized pain scores by participants and/or parents. Score systems: Visual Analog Scale (VAS) or Face Legs Activity Cry Consolability (FLACC) scale, both with scores from 0 (no pain) to 10 (worst pain). \[14 days\]
Time frame: 14 days
Total duration of antibiotic therapy
Time frame: 3 months
Sequelae at 12 months
Proportion of children with sequelae, e.g. abnormal mobility, growth abnormalities assessed by clinical examination by a qualified pediatrician 12 month after initiation of treatment.
Time frame: 12 months
Radiological abnormalities at 12 months
Proportion of children with radiological abnormalities assessed by a qualified radiologist 12 months after the initiation of treatment.
Time frame: 12 months
Secondary infection
Proportion of children with secondary infection with antimicrobial-resistant organisms or Clostridium difficile
Time frame: 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study protocol and statistical analysis plan will be shared. The exact plan for sharing Individual Participant Data (IPD) is being prepared.
Supporting information: Study protocol, Statistical analysis plan
Ran from Sep 2020 to primary completion in Jan 2024, 39 months.
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Copenhagen University Hospital, Rigshospitalet