Oral-only Antibiotics for Bone and Joint Infections in Children

Osteomyelitis Clinical Trial

— CHILD@HOME_BJI  

Official title:

Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04563325
• Other study ID #: H-20009117
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Bone Infection
• Communicable Diseases
• Infections
• Joint Infection
• Osteomyelitis
• Septic Arthritis

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