Clinical trialNATerminated
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures
Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors
- Outcome
- Stopped earlylack of funding (Business decision)
- Phase
- NA
- Status
- Terminated
- Study type
- Interventional
- Start
- 19 January 2023
- Expected end
- 27 November 2023
- Enrollment
- 8 participants
- Sites
- 1
- Primary outcomes
- Number of Participants With Surgical Site Infections; Improved Antibiotic Stewardship - Number of Antibiotics; Improved Antibiotic Stewardship - Duration
- Sponsor
- Other
- Results posted
- 2025-02-18
- Last update
- 18 February 2025
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Brief summary public domain (ClinicalTrials.gov)
This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.
Detailed description public domain (ClinicalTrials.gov)
PRIMARY OBJECTIVE: I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting. SECONDARY OBJECTIVE: I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing. ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing. After completion of study, patients' medical records are reviewed for 30 days.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Surgical Site Infections [Up to 90 days]. Count Of Participants, Participants. Arm I (Biospecimen Collection, Routine Testing) (n=3): 1; Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) (n=5): 2.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Improved Antibiotic Stewardship - Number of Antibiotics [Up to 90 days]. Mean, Antibiotics Administered (Standard Deviation). Arm I (Biospecimen Collection, Routine Testing) (n=3): 7.7 (2.31); Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) (n=5): 5.4 (1.82).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Improved Antibiotic Stewardship - Duration [Up to 90 days]. Mean, Days (Standard Deviation). Arm I (Biospecimen Collection, Routine Testing) (n=3): 21 (14.93); Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) (n=5): 25.2 (23.30).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Timeliness of Sample Analysis [Up to 90 days]. Mean, Hours (Standard Deviation). Arm I (Biospecimen Collection, Routine Testing) (n=3): 163.5 (87.56); Arm II (Biospecimen, Nanopore Sequencing, Routine Testing) (n=5): 60.9 (2.32).