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Completed

NCT Number: NCT04563325

Oral-only Antibiotics for Bone and Joint Infections in Children

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.

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Key information

Conditions

Osteomyelitis Arthritis Arthritis, Infectious Bone Diseases Bone Diseases, Infectious Bone Infection Bone and Joint Infection Infections Joint Diseases Joint Infection Musculoskeletal Diseases Septic Arthritis

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing fasciitis, requiring IV antibiotics in the opinion of the treating clinician.
  • Complicated bone or joint infection, e.g. prosthetic material, infection secondary to or complicated by trauma, severe pyomyositis or other substantial soft tissue infections.
  • 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.
  • Significant co-morbidities that might influence the choice of treatment or the course of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell anemia.
  • Previous bone or joint infection.
  • Antibiotic therapy for more than 24 hours before inclusion.
  • Documented pathogen with limited treatment options that do not permit randomization, e.g. the pathogen is only sensitive to intravenous antibiotics.
  • Prior enrolment in the trial

Treatment and study plan

Oral co-amoxiclav or oral dicloxacillin only

Drug

High dose oral treatment followed by standard dose oral treatment

IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin

Drug

IV treatment followed by standard dose oral treatment

Primary outcomes

  1. Sequelae at 6 months

    Time frame: 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.

Secondary outcomes

  1. Non-acute treatment failure.

    Time frame: 28 days

    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.

  2. Recurrent infection

    Time frame: 6 months

    Proportion of children with recurrence of symptoms and signs (same anatomical location) after completion of antibiotic treatment requiring further antibiotic administration

Other outcomes

  1. Safety Outcome 1: Severe complications during antibiotic treatment.

    Time frame: 28 days

    Proportion of children with severe complications during antibiotic treatment, e.g. need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis.

  2. Safety Outcome 2: Surgical intervention

    Time frame: 28 days

    Proportion of children with need for surgical intervention during antibiotic treatment. Diagnostic surgical intervention (diagnostic joint aspiration or diagnostic bone biopsy) excluded.

  3. Safety Outcome 3: Treatment related adverse events

    Time frame: 3 months

    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).

  4. Time to apyrexia from initiation of antibiotic treatment

    Time frame: 28 days

  5. Mobility and pain

    Time frame: 14 days

    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]

  6. Total duration of antibiotic therapy

    Time frame: 3 months

  7. Sequelae at 12 months

    Time frame: 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.

  8. Radiological abnormalities at 12 months

    Time frame: 12 months

    Proportion of children with radiological abnormalities assessed by a qualified radiologist 12 months after the initiation of treatment.

  9. Secondary infection

    Time frame: 3 months

    Proportion of children with secondary infection with antimicrobial-resistant organisms or Clostridium difficile

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen Health Science Partners
  • Innovation Fund Denmark
  • The research foundation of Copenhagen University Hospital, Rigshospitalet

Registry information

Official study title

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

Acronym: CHILD@HOME_BJI

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 24, 2020
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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