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Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

Study acronym: SPARROW
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 21, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment target: 322 to 344 Eligibility criteria expanded, about 19 words · Site contacts updated at 11 of 11 sitesv3 Show 2 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Site contacts updated at 11 of 11 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2023 to Mar 6, 2023 · Site details revised at 11 of 11 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2023 to Mar 6, 2023
    • Site details revised at 11 of 11 sites
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this multicenter randomized controlled trial is to evaluate the additional value of pre-emptive antibiotic treatment on clinically relevant organ/space surgical site infections (OSIs) in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile. The main objectives it aims to answer are: * To evaluate the effect of pre-emptive antibiotic prophylaxis on clinically relevant OSIs in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile * To evaluate the effect of pre-emptive antibiotic prophylaxis on other postoperative outcomes (e.g. OSIs, superficial SSIs, POPF, PPH, major morbidity, ICU admission, readmission, length of hospital stay, and mortality). * To evaluate concordance between perioperatively obtained bile cultures and postoperative cultures from infectious sites, and to evaluate antibiotic sensitivity patterns of the cultured microorganisms. Participants will be randomized with a 1:1 allocation before surgery into the intervention or control group: * Patients in the intervention group will receive perioperative prophylaxis (similar to the control group) followed by five days of 1500mg IV cefuroxime and 500mg IV metronidazole thrice daily. * Patients in the control group will only receive perioperative prophylaxis (a single dose of 5-7mg/kg gentamicin followed by 2gr IV cefazolin and 500mg IV metronidazole every 4h of surgery), which will be discontinued after surgery.
Trial Details
NCT Number NCT05784311
Lead Sponsor Leiden University Medical Center
Conditions Pancreatic Cancer
Enrollment 344 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov