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Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 271 participants (planned 236)
    • Eligibility criteria expanded, about 9 words
    • Site details revised
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Dec 31, 2024 to Feb 28, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v7
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2024v6
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Dec 31, 2022 to Dec 31, 2024
    v5
  5. 2 versions Re-verified since Jul 20, 2021, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between 1. Six and twelve weeks of antibiotic therapy if there is an implant left in place 2. Three and six weeks of antibiotic therapy if there is no implant left
Trial Details
NCT Number NCT04048304
Lead Sponsor Balgrist University Hospital
Conditions
(from sponsor)		 Infection
Related terms Infections
Enrollment 271 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov