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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05609240
Other study ID # 315251
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 10, 2023
Est. completion date May 1, 2025

Study information

Verified date May 2024
Source University of Leeds
Contact Andrew Kirby
Phone 01133923929
Email a.kirby@leeds.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After a surgical operation patients may have an infection in the operation wound, the bladder, kidneys or lungs. To stop these infections patients are given a dose of antibiotic before their operation. Unfortunately, the amount of antibiotic available to fight infections falls throughout an operation, being removed from the body by the kidneys. Therefore, antibiotic levels may not be high enough to stop infections. A way of maintaining antibiotic levels throughout an operation is to give a single dose of antibiotic and then a constant amount of antibiotic by an infusion from the start to the end of the operation. A small single centre test study was previosuly undertaken into antibiotic dosing during bowel operations. One group of patients had a single dose of antibiotic before their operation. The other group had a single dose plus a constant dose of antibiotic until the end of their operation. The project showed patients were happy to take part and that the study was safe. The study helped us identify the correct amounts of antibiotic needed for the patients given the single dose plus a constant dose of antibiotic. This study was conducted at one hospital only, and wasn't big enough to confirm if one treatment was better than another or if results would be similar in other hospitals. This study will build on the pilot study in a larger feasibility trial, the Colo-Pro_2 trial. It will be run in three hospitals so can assess if the trial design works at different hospitals. We will see if the results suggest one treatment, single dose of antibiotics before an operation, or single dose plus a constant dose of antibiotics throughout an operation, is better. This study will include up to 180 patients having bowel operations as they have a high risk of infection. All patients will be given the same antibiotic which is called cefuroxime. Cefuroxime is already used to stop infections after surgery. Using the same antibiotic in all patients means it is possible to know if differences in the number of infections are due to how the antibiotic is given. The number of infections that happen up to 30 days after operations will be counted. Staff looking after patients after the operation and those counting the infections will not know, unless necessary, the treatment patients received. This means the results won't be influenced by knowledge of the treatment received.


Description:

See attached protocol


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date May 1, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Undergoing elective colorectal surgery (incision, excision or anastomosis of the large bowel, including anastomosis of small to large bowel) - Age >16. - Expected duration of surgery > 2hours - Creatinine clearance > 40 ml/min - Cefuroxime/metronidazole are appropriate antibiotic prophylaxis regimens. - Patient capable of giving informed consent - Patients undergoing colorectal surgery plus additional surgery e.g. plastic surgery, urological surgery, gynaecological surgery. Exclusion Criteria: - Unable to consent - Pregnancy - Expected duration of surgery <2hours - Creatinine clearance <40ml/min - Individual level microbiological advice for non-cefuroxime based prophylaxis - Cephalosporin allergy - Penicillin allergy (hypersensitivity reaction only) - Coumarin (warfarin and acenocoumarol) treatment - Seizure history or epilepsy - Concurrent use of probenecid - Current participation in a research project aimed at reducing surgical site infections (SSIs) - Antibiotics for treatment of a systemic Gram negative infection within 12 hours of initiation of surgery (Vancomycin, Teicoplanin, Daptomycin, Linezolid, Flucloxacillin. Nitrofurantoin and Clarithromycin would be permissible antibiotics without systemic Gram negative antibiotics). - A current diagnosis of infection at the time of study entry. - STARR procedures (stapled trans anal resection of the rectum) - Weight <30kg or >110kg

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cefuroxime
See arm/group description

Locations

Country Name City State
United Kingdom TheUniversity of Birmingham Birmingham West Midlands
United Kingdom Leeds Teaching Hospitals Leeds West Yorkshire
United Kingdom Aneurin Bevan University Health Board Newport

Sponsors (3)

Lead Sponsor Collaborator
University of Leeds Aneurin Bevan University Health Board, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rates Rate of recruitment 24 months
Primary Retention rates Rate of retention 90 days
Secondary Health Care Associated Infection The number of patients within 30 days of surgery with post-operative Health Care Associated Infection (HCAI). This will be defined by post-operative (> 72 hours) evidence of inflammation (fever, neutrophilia, C-Reactive Protein >100mg/L and infection (=5 days prescription of antibiotic therapy) or bacteraemia with a recognised pathogen i.e., not a contaminant namely coagulase negative staphylococcus, Corynebacterium or Propionibacterium. 30 days
Secondary Surgical site infection Superficial, deep and organ space surgical site infection. A wound assessment will be made at day 5 after operation and a questionnaire will be completed at day 30. 30 days
Secondary Microbiological evidence of urinary tract infection (UTI) A urine sample with the detection of E.coli (or other Enterobacterales including Klebsiella, Enterobacter, Serratia, Citrobacter and Proteus) 30 days
Secondary Antimicrobial consumption after colorectal surgery A day on which any antibiotic was consumed by a participant within 90 days of operations. Antibiotic prophylaxis e.g., for urinary tract infection, or splenectomy, are not included. 90 days
Secondary Antimicrobially resistant infections (AMR infections): Infection with an antibiotic resistant bacteria will be identified by the rate of bacteraemia with the following antibiotic resistant bacteria detected in the blood stream:
Methicillin resistant Staphylococcus aureus
Vancomycin resistant Enterococcus faecalis/faecium
Extended spectrum beta-lactamase (ESBL) E.coli (or other Enterobacterales including Klebsiella, Enterobacter, Serratia, Citrobacter and Proteus
Carbapenemase producing Enterobacteriaceae (CPE) E.coli (or other Enterobacterales including Klebsiella, Enterobacter, Serratia, Citrobacter and Proteus)
90 days
Secondary C. difficile infection A diagnosis of C. difficile infection (CDI) is one that requires confirmation of C. difficile toxin on a faeces test. Detection of the toxin gene by molecular testing is not sufficient. If multiple episodes if CDI infection, please report only the first episode 90 days
Secondary Anastomotic leakage after colorectal surgery Radiological or surgical evidence of anastomotic leak 90 days
Secondary Mortality Death 90 days
Secondary Length of hospital stay The number of nights spend as a hospital in-patient within 90 days of operation. 90 days
Secondary Re-admission Readmission to hospital following discharge with at least one night spent as a hospital in-patient. 90 days
Secondary Cost of healthcare treatment Cost of healthcare treatment including days in hospital, surgical procedures and radiological procedures 90 days
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