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Clinical: Colo-Pro: A clinical trial to compare cefuroxime prophylaxis treatment regimes for the prevention of infections after colorectal surgery

PGR-P-394

Key facts

Type of research degree
4 year PhD
Application deadline
Ongoing deadline
Country eligibility
International (outside UK)
Funding
Non-funded
Supervisors
Mr Dermot Burke and Dr Andrew Kirby
Schools
School of Medicine
Research groups/institutes
Leeds Institute of Medical Research at St James's
<h2 class="heading hide-accessible">Summary</h2>

Aims: We want to stop the infections patients suffer after colo-rectal surgery. <br /> Background: Patients in hospital have operations as part of their care. 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. The World Health Organisation recommends trials be completed to find the best way of dosing antibiotics during operations to stop infections. <br />

<h2 class="heading hide-accessible">Full description</h2>

<p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{109}" paraid="1342164052">We carried out a pilot study (90 patients) 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 results indicated that there may be fewer infections, and patients may need to come back to hospital less often in the group who had single dose plus a constant dose of antibiotic. However, this study wasn&rsquo;t big enough to confirm if one treatment was truly better than another.&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{109}" paraid="1342164052">Design and methods: We will build on the pilot study in a larger trial, the Colo-Pro trial. In the future this approach may be a better way of using antibiotics to help patients having different types of operation e.g. bone &amp; pelvic operations.&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{153}" paraid="1679379856">This study will involve administering the same antibiotic, cefuroxime, to all patients. The standard treatment arm will receive cefuroxime 1. 5 grams 4 hourly. The intervention treatment arm will receive a bolus dose of cefuroxime followed by a continuous infusion of cefuroxime until the end of surgery. The cefuroxime dose will vary based on renal function and weight but will target a blood concentration of 64mg/L, which should be sufficient to achieve highly bactericidal concentrations throughout the surgical period.&nbsp;&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{159}" paraid="41739525">The primary outcome will be all infections within 30 days of the operation.&nbsp;&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{169}" paraid="127845855">Mechanistic work:&nbsp;We will look at antibiotic levels in patients during surgery to find out if these are linked to risk of having an infection after the operation. We will look at the types of bacteria found in patients e.g. in the bowel, before an operation, to see if this explains why infections occur after surgery.&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{169}" paraid="127845855">Techniques associated with the project</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{169}" paraid="127845855">Clinical Trial Research Governance,&nbsp;Health Research Authority approvals (including ethical approval),&nbsp;Patient recruitment,&nbsp;Patient trial follow up,&nbsp;Microbiological sampling,&nbsp;Microbiological culture&nbsp;and antibiotic susceptibility testing.&nbsp;</p> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{242}" paraid="1268045221">References</p> <ol role="list" start="1"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="1" data-font="Arial" data-leveltext="%1-" data-listid="20" role="listitem"> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{246}" paraid="2127529618">Kirby A et al. Colo-Pro: a pilot randomised controlled trial to compare standard bolus-dosed cefuroxime prophylaxis to bolus-continuous infusion-dosed cefuroxime prophylaxis for the prevention of infections after colorectal surgery. Eur J Clin Microbiol Infect Dis. 2019:8;357-363.&nbsp;</p> </li> </ol> <ol role="list" start="2"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="2" data-font="Arial" data-leveltext="%1-" data-listid="20" role="listitem"> <p paraeid="{390a251e-8acb-416c-9a95-6bddfbc448b1}{253}" paraid="1567898285">Kirby A et al. Postoperative infections following colorectal surgery in an English teaching hospital. Infectious Diseases. 2015:47;829-833.&nbsp;</p> </li> </ol> <ol role="list" start="3"> <li aria-setsize="-1" data-aria-level="1" data-aria-posinset="3" data-font="Arial" data-leveltext="%1-" data-listid="20" role="listitem"> <p paraeid="{670590f4-12a9-45e7-aa42-e212881b047c}{5}" paraid="2056671839">Kirby A et al. Microbiological prediction of surgical site infection risk after colorectal surgery: a feasibility study. Journal of Hospital Infection. 2015:90;271-27.&nbsp;</p> </li> </ol> <p>This project is part of the&nbsp;<a href="https://medicinehealth.leeds.ac.uk/leeds-institute-research-st-james/doc/international-phd-academy-medical-research">International PhD Academy: Medical Research</a></p> <p><strong>In line with the bespoke nature of our International PhD Academy a modified PhD project can be proposed dependent on students interests and background.</strong></p>

<h2 class="heading">How to apply</h2>

<p>Please note these are not standalone projects and applicants must apply to the PhD academy directly.</p> <p>Applications can be made at any time. To apply for this project applicants should complete an <a href="http://www.leeds.ac.uk/info/130206/applying/91/applying_for_research_degrees">online application form</a> and submit this&nbsp;alongside a full academic CV, degree transcripts (or marks so far if still studying) and degree certificates. Please make it clear in the research information section that you are applying for the International PhD Academy: Medical Research, as well as the title of the project you wish to be considered for.</p> <p>We also require 2 academic references to support your application. Please ask your referees to send these <a href="https://medicinehealth.leeds.ac.uk/downloads/download/130/faculty_graduate_school_-_scholarship_reference_form">references</a> on your behalf, directly to <a href="mailto:fmhpgradmissions@leeds.ac.uk">fmhpgradmissions@leeds.ac.uk</a></p> <p>If English is not your first language, you must provide evidence that you meet the University&#39;s minimum English language requirements (below).</p>

<h2 class="heading heading--sm">Entry requirements</h2>

A degree in biological sciences, dentistry, medicine, midwifery, nursing, psychology or a good honours degree in a subject relevant to the research topic. A Masters degree in a relevant subject may also be required in some areas of the Faculty. For entry requirements for all other research degrees we offer, please contact us.

<h2 class="heading heading--sm">English language requirements</h2>

Applicants whose first language is not English must provide evidence that their English language is sufficient to meet the specific demands of their study. The Faculty of Medicine and Health minimum requirements in IELTS and TOEFL tests for PhD, MSc, MPhil, MD are: &bull; British Council IELTS - score of 7.0 overall, with no element less than 6.5 &bull; TOEFL iBT - overall score of 100 with the listening and reading element no less than 22, writing element no less than 23 and the speaking element no less than 24.

<h2 class="heading">Contact details</h2>

<p>Informal enquires about regarding the bespoke taught first year of the PhD programme and research projects can be made by contacting LIMRPhD@leeds.ac.uk.</p> <p>Enquiries regarding the application process should be directed to the Faculty of Medicine and Health Graduate School Office e: <a href="mailto:fmhpgradmissions@leeds.ac.uk">fmhpgradmissions@leeds.ac.uk</a>, t: +44 (0)113 343 8221.</p>


<h3 class="heading heading--sm">Linked research areas</h3>