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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
| Aneurin Bevan University Health Board | OTHER |
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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.
See attached protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | Cefuroxime 1.5 grams intravenous Administered in the hour before surgery and then 4 hourly intra-operatively. |
|
| Intervention treatment | Active Comparator | Cefuroxime loading dose of 2332mg intravenous Administered in the hour before surgery. Following the loading dose a renal function based dosing will be given as a continuous intravenous infusion throughout surgery, as below. Continuous infusion will continue for up to 6 hours when it will return to 4 hourly dosing of cefuroxime at 1.5 grams intravenously, if required. Creatinine clearance (ml/min) and Cefuroxime:Dose per hour (mg/hr) 40-50ml/min=723mg/hr 50-60ml/min=867mg/hr 60-70ml/min=1011mg/hr 70-80ml/min=1155mg/hr >80ml/min=1227mg/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefuroxime | Drug | See arm/group description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rates | Rate of recruitment | 24 months |
| Retention rates | Rate of retention | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Kirby | Contact | 01133923929 | a.kirby@leeds.ac.uk | |
| Dermot Burke | Contact | 0113 3923465 | d.burke@leeds.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Kirby | The Univeristy of Leeds | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TheUniversity of Birmingham | Not yet recruiting | Birmingham | West Midlands | B15 2TT | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 30, 2025 | |
| Reset | Jan 20, 2026 | |
| Release | Jan 21, 2026 | |
| Reset | Feb 6, 2026 | |
| Release | Feb 7, 2026 | |
| Reset | Feb 25, 2026 | |
| Release | Feb 26, 2026 | |
| Reset | Mar 18, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 30, 2025 | Jan 20, 2026 | |||
| Jan 21, 2026 |
| ID | Term |
|---|---|
| D002444 | Cefuroxime |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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An anaesthetist will provide the intra-operative intervention and will the subsequently not be involved in the patients follow up or outcome assessment. alternatively, a research nurse not involved in participant follow up will provide the intra-operative intervention.
| 30 days |
| 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 |
| 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 |
| 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 |
| 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:
| 90 days |
| 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 |
| Anastomotic leakage after colorectal surgery | Radiological or surgical evidence of anastomotic leak | 90 days |
| Mortality | Death | 90 days |
| Length of hospital stay | The number of nights spend as a hospital in-patient within 90 days of operation. | 90 days |
| Re-admission | Readmission to hospital following discharge with at least one night spent as a hospital in-patient. | 90 days |
| Cost of healthcare treatment | Cost of healthcare treatment including days in hospital, surgical procedures and radiological procedures | 90 days |
| Leeds Teaching Hospitals | Recruiting | Leeds | West Yorkshire | LS17 9EJ | United Kingdom |
|
| Aneurin Bevan University Health Board | Recruiting | Newport | NP20 2UB | United Kingdom |
|
| Feb 6, 2026 |
| Feb 7, 2026 | Feb 25, 2026 |
| Feb 26, 2026 | Mar 18, 2026 |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |