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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04563325
Other study ID # H-20009117
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date September 15, 2020
Est. completion date September 15, 2024

Study information

Verified date December 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date September 15, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 17 Years
Eligibility 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

Study Design


Intervention

Drug:
Oral co-amoxiclav or oral dicloxacillin only
High dose oral treatment followed by standard dose oral treatment
IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin
IV treatment followed by standard dose oral treatment

Locations

Country Name City State
Denmark Copenhagen University Hospital, Rigshospitalet Copenhagen

Sponsors (4)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Copenhagen Health Science Partners, Innovation Fund Denmark, The research foundation of Copenhagen University Hospital, Rigshospitalet

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Outcome 1: Severe complications during antibiotic treatment. Proportion of children with severe complications during antibiotic treatment, e.g. need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis. 28 days
Other Safety Outcome 2: Surgical intervention Proportion of children with need for surgical intervention during antibiotic treatment. Diagnostic surgical intervention (diagnostic joint aspiration or diagnostic bone biopsy) excluded. 28 days
Other Safety Outcome 3: Treatment related adverse events Proportion of children with treatment related adverse events e.g. complications of IV access (infection, need for replacement, extravasation) and drug side effects reported by medical staff or by parents (electronic questionnaire). 3 months
Other Time to apyrexia from initiation of antibiotic treatment 28 days
Other Mobility and pain Level of mobility and pain assessed by daily grading of symptoms by medical staff as well as daily standardized pain scores by participants and/or parents. Score systems: Visual Analog Scale (VAS) or Face Legs Activity Cry Consolability (FLACC) scale, both with scores from 0 (no pain) to 10 (worst pain). [14 days] 14 days
Other Total duration of antibiotic therapy 3 months
Other Sequelae at 12 months Proportion of children with sequelae, e.g. abnormal mobility, growth abnormalities assessed by clinical examination by a qualified pediatrician 12 month after initiation of treatment. 12 months
Other Radiological abnormalities at 12 months Proportion of children with radiological abnormalities assessed by a qualified radiologist 12 months after the initiation of treatment. 12 months
Other Secondary infection Proportion of children with secondary infection with antimicrobial-resistant organisms or Clostridium difficile 3 months
Primary Sequelae at 6 months Proportion of children with sequelae 6 months after initiation of treatment defined as abnormal mobility or function of the affected joint/bone. Evaluated by blinded clinical examination by a qualified pediatrician and/or pediatric orthopedic surgeon. 6 months
Secondary Non-acute treatment failure. Proportion of children with change of antibiotic therapy due to non-acute treatment failure. This will be evaluated by two pediatric specialists and is suggested by e.g. 1) temperature above 38,5 after more than 72 hours of antibiotic therapy, 2) increasing CRP ( C-reactive protein) after more than 96 hours of antibiotic therapy and 3) no improvement in mobility or pain after 120 hours of antibiotic therapy. 28 days
Secondary Recurrent infection Proportion of children with recurrence of symptoms and signs (same anatomical location) after completion of antibiotic treatment requiring further antibiotic administration 6 months
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