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BonE and Joint Infections - Simplifying Treatment in Children Trial

Study acronym: BEST
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 10 sitesv8
  2. Study sites: 9 to 10v7
  3. Study sites: 8 to 9v6
  4. Site details revised at 7 of 8 sitesv5
  5. Secondary endpoints: details revised at 2 of 12 entries Eligibility criteria expanded, about 2 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

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  1. Primary and study completion dates: Sep 2023 to Dec 2026 Enrollment target: 214 to 285 · Study sites: 1 to 8 · Interventions: IV cefazolin followed by oral cefalexin (Drug), Oral cefalexin only (Drug) to IV cefazolin or IV flucloxacillin followed by oral cefalexin (Drug), Oral cefalexin only (Drug) · 3 morev3 Show 6 more changesShow less
    • Enrollment target: 214 to 285
    • Study sites: 1 to 8
    • Interventions: IV cefazolin followed by oral cefalexin (Drug), Oral cefalexin only (Drug) to IV cefazolin or IV flucloxacillin followed by oral cefalexin (Drug), Oral cefalexin only (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 10 to 12
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2020 to Jun 1, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2020 to Jun 1, 2021
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04538053
Lead Sponsor Murdoch Childrens Research Institute
Conditions Bone Infection, Septic Arthritis, Bone and Joint Infection, Osteomyelitis
Enrollment 285 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov