Surgical Site InfectionPhase 2Colo-ProNCT02445859

Continuous Antibiotic Prophylaxis in Colorectal Surgery

A Phase 2 study testing Cefuroxime 4 hourly bolus in people with Surgical Site Infection, run by University of Leeds at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Site Infection
What is being tested?: Cefuroxime 4 hourly bolus
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2015to May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Undergoing colorectal surgery (incision, excision or anastomosis of the large bowel, including anastomosis of small to large bowel)
Age >18.
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.
If it is not possible to obtain intra-operative blood samples e.g. difficult vascular access, or pre-operative swabs e.g. anatomy makes it difficult to obtain, patients will be included and this information treated as missing data. Patients on antibiotic treatment for an existing infection (except SSIs) can be included in the study

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

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Penicillin allergy (hypersensitivity reaction only)
Coumarin (warfarin and acenocoumarol) treatment
Active blood borne virus infection e.g. HIV, hepatitis.
Seizure history
Concurrent use of probenecid
Current participation in a research project aimed at reducing SSIs
Antibiotics for treatment of a systemic Gram negative infection within 2 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 a SSI at the time of study entry.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX

Other trials in United Kingdom

About this study

Official title: Colo-Pro Pilot: A Pilot Study to Compare Standard Single Dose Antibiotic Prophylaxis to Bolus-continuous Infusion Dosed Antibiotic Prophylaxis for the Prevention of Infections After Colorectal Surgery

We propose to randomise patients due to undergo colorectal surgery to standard antibiotic prophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical wound infection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime, repeated every 4 hours. The intervention regimen is a loading dose of cefuroxime followed by a continuous infusion of cefuroxime until the end of surgery. The intervention regimen dosing will be calculated using a patient's renal function and body weight. The intervention regimen will target a free serum drug concentration of 64mg/L. This serum level is 4x the MIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarised below. The primary objective of the study is to reduce by 50% the rate of surgical wound infections after colorectal surgery.

Read the detailed description

An expert assessment is that fT>MIC is the measure most likely to be applicable to prophylaxis. But this measure is not achieved by standard prophylaxis regimens. Neither do clinical data suggest this target achieves optimal prophylaxis. Therefore there is an opportunity to optimise antibiotic prophylaxis dosing. As the exposure response-relationship (pharmacodynamic target) is unknown we could either complete a number of studies exploring different relationships, or compare standard treatment to a single regimen which included a number of exposure-response relationships. The two most common exposure-response relationships are the CMAX/MIC ratio and the fT>MIC. And it has been reported that killing, as opposed to inhibition used in MIC values, is optimised by achieving 4 times an MIC value. An antibiotic prophylaxis regimen which achieved drug concentrations of 4xMIC for the duration of surgery would therefore achieves a high CMAX/MIC ratio, high T>MIC, and optimise bacterial killing. Therefore, standard dose antibiotic prophylaxis will be compared against a PD target dosed antibiotic prophylaxis regimen. The PD target will be a free serum antibiotic concentration of 4xMIC90 for Enterobacteriaceae against cefuroxime. Continuous infusion of antibiotic prophylaxis will ensure there is continuous targeting of this drug level throughout the operation.

Conditions: Surgical Site Infection
Being tested: Cefuroxime 4 hourly bolus
Keywords: Antibiotic, prophylaxis, surgical site infection
Medical subject headings: Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cefuroxime 4 hourly bolusDrug
Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.

Study groups in NCT02445859
Study group	Role	What they receive
Standard regimen	Active comparator	Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Receives: Drug: Cefuroxime 4 hourly bolus
Interventional regimen	Experimental	Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Receives: Drug: Cefuroxime 4 hourly bolus

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With a Surgical Site Infection
Superficial and deep surgical site infections as defined by the CDC (Centre's for Disease Control) definitions of surgical site infections.
Measured: Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015May 2017

First posted15 May 2015 (estimated)
Study startAug 2015
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Surgical Site InfectionStudies 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: Single blind
Who is masked: Participant
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02445859
Sponsor's protocol ID: MB15/130
Acronym: Colo-Pro
Status last verified: Oct 2019
First submitted: 13 May 2015
Last updated: 10 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Kirby A, Asin-Prieto E, Burns FA, Ewin D, Fatania K, Kailavasan M, Nisar S, Pericleous A, Troconiz IF, Burke D. 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 Feb;38(2):357-363. doi: 10.1007/s10096-018-3435-z. Epub 2018 Dec 5.
PubMed 30519893

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Site Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Colo-Pro Pilot: A Pilot Study to Compare Standard Single Dose Antibiotic Prophylaxis to Bolus-continuous Infusion Dosed Antibiotic Prophylaxis for the Prevention of Infections After Colorectal Surgery
ClinicalTrials.gov ID: NCT02445859
Acronym / sponsor ID: Colo-Pro / MB15/130
Conditions: Surgical Site Infection
Keywords: Antibiotic, prophylaxis, surgical site infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: University of LeedsUniversity, hospital or other
Study start: Aug 2015 (actual)
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 15 May 2015 (estimated)
Results: Posted 12 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Standard regimen	Active comparator	Drug: Cefuroxime 4 hourly bolusCefuroxime 1.5grams pre-operatively Repeated every 4 hours
Interventional regimen	Experimental	Drug: Cefuroxime 4 hourly bolusCefuroxime continuous infusion targeting 64mg/l serum concentrations.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Undergoing colorectal surgery (incision, excision or anastomosis of the large bowel, including anastomosis of small to large bowel)
Age >18.
Expected duration of surgery > 2hours
Creatinine clearance > 40 ml/min
Cefuroxime/metronidazole are appropriate antibiotic prophylaxis regimens.

Key exclusion criteria (14 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
Cefuroxime 4 hourly bolusCefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.	Drug	Interventional regimen, Standard regimen

Primary outcome

Number of Patients With a Surgical Site Infection
Time frame: Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.
Superficial and deep surgical site infections as defined by the CDC (Centre's for Disease Control) definitions of surgical site infections.

Results and safety

Results posted to the registry on 12 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Regimen	45	43
Interventional Regimen	45	42

Primary outcome: Number of Patients With a Surgical Site Infection

Time frame: Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.. Count of participants. Unit: Participants

Measure	Standard Regimen n = 43	Interventional Regimen n = 42
Value	10	13

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Regimen	3 of 43 (7%)	0 of 43 (0%)	0 of 43
Interventional Regimen	5 of 42 (11.9%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): These patients are expected to have multiple adverse events. We only formally collected all serious adverse events, plus specific events e.g. C.difficile. As a pilot trial we have learned about the collection of adverse events in this patient group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30519893Kirby A, Asin-Prieto E, Burns FA, Ewin D, Fatania K, Kailavasan M, Nisar S, Pericleous A, Troconiz IF, Burke D. 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 Feb;38(2):357-363. doi: 10.1007/s10096-018-3435-z. Epub 2018 Dec 5.
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 principal investigator

The University of Leeds

1 site 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 4 hourly bolus in people with Surgical Site Infection, run by University of Leeds at 1 site 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With a Surgical Site Infection (time frame: Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02445859, which also lists 1 linked publication.

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 10 Oct 2019.