drugset / Trial / NCT05753735
eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce CR-POPF
RandomizedParallel-groupOpen-labelSupportive care
Summary
The purpose of this clinical trial is to investigate if prolonged antibiotics after pancreatoduodenectomy can prevent the development of a pancreatic fistula and related complications. Participants who are at high risk of pancreatic fistula will be administered an extended course of antibiotics. While inpatient, the patient will receive these antibiotics through the vein, and after discharge, the antibiotics will be taken by mouth.
Timeline
- Start
- 2024-01-18
- Primary completion
- 2024-03-14
- Completion
- 2024-06-02
Publications
- Loftus A, Wu VS, Elshami M, Hue JJ, Ocuin LM. Hospital charge and resource use analysis of extended-spectrum penicillin antibiotic therapy after pancreatoduodenectomy in intermediate- and high-risk patients. HPB (Oxford). 2025 Jan;27(1):63-70. doi: 10.1016/j.hpb.2024.09.011. Epub 2024 Sep 28.
- Ocuin LM, Loftus A, Elshami M, Hue JJ, Musonza T, Ammori JB, Winter JM, Hardacre JM. Extended antibiotic therapy is associated with a lower rate of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy in intermediate- and high-risk patients: A single-institution analysis. Surgery. 2024 Feb;175(2):477-483. doi: 10.1016/j.surg.2023.09.049. Epub 2023 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 875 mg | Oral |
| Subject | Piperacillin | Small molecule | — | Intravenous |
| Subject | Tazobactam | Small molecule | — | Intravenous |
| Subject | clavulanic acid | Small molecule | 125 mg | Oral |