Clinical trial NCT04538053: BonE and Joint Infections - Simplifying Treatment in Children Trial
Official title: BonE and Joint Infections - Simplifying Treatment in Children Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bone Infection
Septic Arthritis
Bone and Joint Infection
Osteomyelitis
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 285
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'standard treatment group' will receive standard treatment for BJIs, which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics. Children in the 'entirely oral treatment group' will receive high dose oral antibiotics, followed by the standard dose of oral antibiotics for 3 weeks. The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics.

Eligibility criteria: Inclusion Criteria:

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

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. necrosing fasciitis
4. 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)
5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
7. Prior episode of OM or SA
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

Primary outcomes:
measure: Proportion of children assessed as having made a full recovery 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of children with with recurrent disease at 6 months.
timeFrame: 6 months
measure: Proportion of children with with recurrent disease at 12 months.
timeFrame: 12 months
measure: Proportion of children with complications of their disease at 3 months.
timeFrame: 3 months
measure: Proportion of children with complications of their disease at 12 months.
timeFrame: 12 months
measure: Proportion of children with treatment-related adverse effects (AEs).
timeFrame: Between Day 1-7
measure: Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months
timeFrame: 3 months
measure: Quality of life - Child Health Utility Scale (CHU9D) Day 8-14
timeFrame: Once between Day 8 to Day 14
measure: Quality of life - Child Health Utility Scale (CHU9D) 12 months
timeFrame: 12 months
measure: Quality of life - EQ-5d Day 8-14
timeFrame: Once between Day 8 to Day 14
measure: Cost effectiveness - cost-effectiveness ratio of all resources at 12 months
timeFrame: 12 months
measure: Treatment adherence - medication reconciliation at 3 weeks
timeFrame: Week 3
measure: Treatment adherence - Medication Adherence Response Scale at 3 weeks
timeFrame: Week 3
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Children's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Children's Hospital Network
state: New South Wales
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Darwin
country: Australia
facility: Royal Darwin Hospital
state: Northern Territory
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
state: Victoria
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Amanda Gwee, PhD
role: PRINCIPAL_INVESTIGATOR
References: