Antibiotic ProphylaxisPhase 2NCT05609240
Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery
A Phase 2 study testing Cefuroxime in people with Antibiotic Prophylaxis and Colorectal Surgery, run by University of Leeds at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Antibiotic Prophylaxis, Colorectal Surgery
- What is being tested?
- Cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 10 May 2023to 1 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to consent
- Pregnancy
- Expected duration of surgery <2hours
- Creatinine clearance <40ml/min
- Individual level microbiological advice for non-cefuroxime based prophylaxis
- Cephalosporin allergy
Show all 15Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
TheUniversity of Birmingham
Birmingham, West Midlands, B15 2TT
Thomas Pinkney, MBChB, t.pinkney@bham.ac.uk
- Recruiting
Leeds Teaching Hospitals
Leeds, West Yorkshire, LS17 9EJ
Andrew Kirby, MBChB, 0113 3923929, a.kirby@leeds.ac.uk
Dermot Burke, MBChB, 0113 392 3465, d.burke@leeds.ac.uk
- Recruiting
Aneurin Bevan University Health Board
Newport, NP20 2UB
Tamas Szakmay, MBChB, Tamas Szakmany <szakmanyt1@cardiff.ac.uk>
About this study
Official title: Colo-Pro_2: A Feasibility Randomised Controlled Double Blind Trial to Compare Standard Bolus Dosed Cefuroxime Prophylaxis to Bolus-continuous Infusion Dosed Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery
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.
Read the detailed description
See attached protocol
- Conditions
- Antibiotic Prophylaxis, Colorectal Surgery
- Being tested
- Cefuroxime
- Keywords
- Cefuroxime, Antibiotic, Colorectal, Prophylaxis, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefuroximeDrug
Also called Cefuroxime sodium for injection
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Cefuroxime 1.5 grams intravenous Administered in the hour before surgery and then 4 hourly intra-operatively. Receives: Drug: Cefuroxime |
| 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 Receives: Drug: Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Rate of recruitment
Measured: 24 months
Retention rates
Rate of retention
Measured: 90 days
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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:
- 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)
Measured: 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
Measured: 90 days
Anastomotic leakage after colorectal surgery
Radiological or surgical evidence of anastomotic leak
Measured: 90 days
Mortality
Death
Measured: 90 days
Length of hospital stay
The number of nights spend as a hospital in-patient within 90 days of operation.
Measured: 90 days
Re-admission
Readmission to hospital following discharge with at least one night spent as a hospital in-patient.
Measured: 90 days
Cost of healthcare treatment
Cost of healthcare treatment including days in hospital, surgical procedures and radiological procedures
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start10 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham, Aneurin Bevan University Health Board
- Responsible party
- Principal investigator, Andrew Kirby, University of Leeds
- Investigators
- Andrew Kirby, Study chair, The Univeristy of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609240
- Sponsor's protocol ID
- 315251
- Status last verified
- May 2024
- First submitted
- 1 Nov 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colo-Pro_2: A Feasibility Randomised Controlled Double Blind Trial to Compare Standard Bolus Dosed Cefuroxime Prophylaxis to Bolus-continuous Infusion Dosed Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT05609240
- Acronym / sponsor ID
- 315251
- Conditions
- Antibiotic Prophylaxis, Colorectal Surgery
- Keywords
- Cefuroxime, Antibiotic, Colorectal, Prophylaxis, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Birmingham, Aneurin Bevan University Health Board
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
See attached protocol
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Drug: CefuroximeCefuroxime 1.5 grams intravenous Administered in the hour before surgery and then 4 hourly intra-operatively. |
| Intervention treatment | Active comparator | Drug: CefuroximeCefuroxime 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- Unable to consent
- Pregnancy
- Expected duration of surgery <2hours
- Creatinine clearance <40ml/min
- Individual level microbiological advice for non-cefuroxime based prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefuroximeAlso: Cefuroxime sodium for injectionSee arm/group description | Drug | Intervention treatment, Standard treatment |
Primary outcome
Recruitment rates
Time frame: 24 months
Rate of recruitment
Retention rates
Time frame: 90 days
Rate of retention
11 secondary outcomes
Health Care Associated Infection
Time frame: 30 days
Surgical site infection
Time frame: 30 days
Microbiological evidence of urinary tract infection (UTI)
Time frame: 30 days
Antimicrobial consumption after colorectal surgery
Time frame: 90 days
Antimicrobially resistant infections (AMR infections):
Time frame: 90 days
C. difficile infection
Time frame: 90 days
Anastomotic leakage after colorectal surgery
Time frame: 90 days
Mortality
Time frame: 90 days
Length of hospital stay
Time frame: 90 days
Re-admission
Time frame: 90 days
Cost of healthcare treatment
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Kirby study chair
The Univeristy of Leeds
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cefuroxime in people with Antibiotic Prophylaxis and Colorectal Surgery, run by University of Leeds at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew Kirby (01133923929, a.kirby@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.