NCT04538053 BonE and Joint Infections - Simplifying Treatment in Children Trial
| NCT ID | NCT04538053 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Bone Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 214 participants in total. It began in 2021-06-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multi- centre trial of children with bone and joint infections (BJIs) at eleven major paediatric hospitals in Australia, New Zealand and Ireland. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
Eligibility Criteria
Inclusion Criteria: 1. Children aged 1 to 18 years with acute, uncomplicated, uncomplicated, haematogenous osteomyelitis or septic arthritis 2. Symptoms are present for ≤10 days 3. Osteomyelitis (OM): involvement of long bones of arm or leg AND either pain, point tenderness upon palpation of bone or joint, or difficulty weight bearing; OR Septic arthritis (SA): any of painful and/or swollen large joint; restriction of joint movement; tenderness or warmth. Those with both SA and OM at the same site as the current infection are also eligible. 4. The participant has an elevated C-reactive protein (CRP) ≥20 mg/L or erythrocyte sedimentation rate (ESR) ≥10 mm/h Exclusion Criteria: 1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal) 2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score) 3. Concomitant severe, invasive infection e.g. necrotising fasciitis 4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal or intraosseous (either \>3 mm) abscess or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma) 5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins 6. Received more than four IV or oral doses of an antibiotic with activity against the likely bacteria causing the current infection 7. Prior episode of osteomyelitis (OM) or septic arthritis (SA) of the same site 8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency) 9. Prior enrolment in the trial 10. Current recipient of another investigational product as part of a clinical trial
Contact & Investigator
Amanda Gwee, PhD
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT04538053 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Bone Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04538053 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04538053 currently recruiting?
Yes, NCT04538053 is actively recruiting participants. Contact the research team at alison.boast@gmail.com for enrollment information.
Where is the NCT04538053 trial being conducted?
This trial is being conducted at Kingswood, Australia, New Lambton Heights, Australia, Sydney, Australia, Sydney, Australia and 7 additional locations.
Who is sponsoring the NCT04538053 clinical trial?
NCT04538053 is sponsored by Murdoch Childrens Research Institute. The principal investigator is Amanda Gwee, PhD at Murdoch Childrens Research Institute. The trial plans to enroll 214 participants.