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New treatment option for Bone Infection
Official title BonE and Joint Infections - Simplifying Treatment in Children Trial
ClinicalTrials.gov ID: NCT04538053
What this study is testing
What is Oral cefalexin only?
Oral cefalexin only is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bone infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
You likely can't join if
- Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)
- Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2...
- Concomitant severe, invasive infection e.g. necrosing fasciitis
- Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\>3mm) or soft tissue abscess without surgical intervention...
- History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
- Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
See the full eligibility criteria
- Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
- Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)
- Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)
- Concomitant severe, invasive infection e.g. necrosing fasciitis
- Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)
- History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
- Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
- Prior episode of OM or SA
- Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)
- Prior enrolment in the trial
- Current recipient of another investigational product as part of a clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Kingswood, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Sydney, New South Wales, Australia
- Darwin, Northern Territory, Australia
- Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Christchurch, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingswood, New South Wales, Australia; New Lambton Heights, New South Wales, Australia; Sydney, New South Wales, Australia; Darwin, Northern Territory, Australia; Brisbane, Queensland, Australia; Adelaide, South Australia, Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.