Clinical trial NCT04563325: Oral-only Antibiotics for Bone and Joint Infections in Children
Official title: Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteomyelitis
Septic Arthritis
Bone Infection
Joint Infection
Bone and Joint Infection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The research foundation of Copenhagen University Hospital, Rigshospitalet
name: Copenhagen Health Science Partners
name: Innovation Fund Denmark
First posted: 2020-09-24
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Children aged 3 months to 18 years with antibiotic treatment of uncomplicated bone or joint infection.

Exclusion Criteria:

1. Severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing fasciitis, requiring IV antibiotics in the opinion of the treating clinician.
2. Complicated bone or joint infection, e.g. prosthetic material, infection secondary to or complicated by trauma, severe pyomyositis or other substantial soft tissue infections.
3. Expected need of major surgery within the first 24 hours of treatment, e.g. drilling, debridement, fenestration, surgical drainage, synovectomy. Minor surgery as diagnostic surgical bone biopsy or diagnostic joint fluid aspiration including lavage is not a criterion for exclusion.
4. Significant co-morbidities that might influence the choice of treatment or the course of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell anemia.
5. Previous bone or joint infection.
6. Antibiotic therapy for more than 24 hours before inclusion.
7. Documented pathogen with limited treatment options that do not permit randomization, e.g. the pathogen is only sensitive to intravenous antibiotics.
8. Prior enrolment in the trial

Primary outcomes:
measure: Sequelae at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Non-acute treatment failure.
timeFrame: 28 days
measure: Recurrent infection
timeFrame: 6 months
Other outcomes:
measure: Safety Outcome 1: Severe complications during antibiotic treatment.
timeFrame: 28 days
measure: Safety Outcome 2: Surgical intervention
timeFrame: 28 days
measure: Safety Outcome 3: Treatment related adverse events
timeFrame: 3 months
measure: Time to apyrexia from initiation of antibiotic treatment
timeFrame: 28 days
measure: Mobility and pain
timeFrame: 14 days
measure: Total duration of antibiotic therapy
timeFrame: 3 months
measure: Sequelae at 12 months
timeFrame: 12 months
measure: Radiological abnormalities at 12 months
timeFrame: 12 months
measure: Secondary infection
timeFrame: 3 months
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Allan Bybeck Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Ulrikka Nygaard, Ass Prof PhD
role: STUDY_CHAIR
References: