Health TrialsbyHealthPanel

BonE and Joint Infections - Simplifying Treatment in Children Trial

ConditionsBone InfectionSeptic ArthritisBone and Joint InfectionOsteomyelitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-18
SponsorMurdoch Childrens Research Institute

About this trial

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. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral cefalexin only

    Drug

    High-dose oral cefalexin

  • IV cefazolin or IV flucloxacillin followed by oral cefalexin

    Drug

    Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin

Treatment groups

285 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: Standard TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of children assessed as having made a full recovery 3 months

Full recovery is defined by the absence of: (i) Clinical features of osteomyelitis or septic arthritis (ii) No episodes of disease recurrence requiring further antibiotic administration after initial treatment. Assessment made by a qualified paediatrician.

Time frame
3 months

Secondary outcomes

1

Proportion of children with with recurrent disease at 6 months.

Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 3 months by an independent committee.

Time frame
6 months
2

Proportion of children with with recurrent disease at 12 months.

Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 12 months by an independent committee.

Time frame
12 months
3

Proportion of children with complications of their disease at 3 months.

Complications assessed by an independent committee defined as: (i) residual dysfunction (ii) pain

Time frame
3 months
4

Proportion of children with complications of their disease at 12 months.

Complications assessed by an independent committee defined as: (i) residual poor function (ii) bone death (osteonecrosis) (iii) pain (iv) growth arrest (v) limb deformity

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Murdoch Childrens Research Institute

Lead sponsor

Source ClinicalTrials.gov
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