Anti-bacterial AgentsNCT05253339
The Expected Advantage of Administering Prophylactic Antibiotics Using Target- Concentration Controlled Infusion
A study testing Standard administration method in people with Anti-bacterial Agents and Pharmacokinetics, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Preoperative antimicrobial prophylaxis is a key element for the prevention of surgical site infection, the most common type of nosocomial infection in surgical patients. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anti-bacterial Agents, Pharmacokinetics, General Surgery
- What is being tested?
- Standard administration method
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,494 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Apr 2022to 28 Aug 2025
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years old
- Patients who are scheduled to undergo colon or rectal surgery
- Patients scheduled to receive cefoxitin as a prophylactic antibiotic
Who cannot join
- Known allergies, hypersensitivity, or intolerance to cefoxitin
- Patients with a history of receiving cefoxitin within 3 days of the scheduled surgery time
- Patients receiving therapeutic antibiotics
- eGFR < 30 ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Randomized Controlled Trial Comparing the Standard Method and Target-controlled Infusion as a Method of Administering Cefoxitin, Which is Used to Prevent Surgical Site Infections in Colorectal Surgical Patients
Preoperative antimicrobial prophylaxis is a key element for the prevention of surgical site infection, the most common type of nosocomial infection in surgical patients. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery. Cefoxitin is generally dissolved in normal saline and intravenously administered for a short time of 5-10 minutes before skin incision. However, there are several drawbacks to the current dosing strategy. First, the dose of cefazolin is determined by a "rule of thumb", and there is controversy over whether 1 g or 2 g is appropriate, with the opinion that 2 g being more appropriate prevailing. Second, the standard administration method unnecessarily induces a concentration higher than the concentration required to prevent surgical site infection. Third, significant covariates that can affect the maintenance of MIC during surgery are not considered. The target-concentration controlled infusion (TCI) method can be a viable alternative administration method for antibiotics. The TCI method enables individual customized administration according to the covariates (i.e., weight, creatinine clearance) included in the pharmacokinetic parameters; also, although with some variability, the drug can be administered while maintaining the target concentration. The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function
Read the detailed description
Parenteral antimicrobial prophylaxis before abdominal surgery for preventing surgical site infection (SSI) is a well-established clinical practice. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. These antibiotics are generally dissolved in normal saline and intravenously administered for a short time of 5-10 min before skin incision. However, the conventional administration strategy has several problems. First, the dose of antibiotics does not take into account the patients' physical characteristics such as body weight, age, and renal function. Considering that the dosages of practically all drugs used in clinical fields are determined based on body weight, it may be necessary to improve the dosing strategy to reflect the patient's physical characteristics based on the effectiveness and safety of the antibiotic. Second, the plasma concentration of cephalosporin becomes excessively high at the end of the administration, which is more pronounced in patients with low body weight. The minimal inhibitory concentrations (MIC) for each antibiotic are well-characterized; however, a pilot simulation study showed that at the end of the administration, the plasma concentration of cefazolin was 20 times higher than its MIC. It is difficult to exclude the possibility that concentrations higher than necessary may cause harm to patients. Third, the bactericidal activity of an antibiotic is apparent when its free plasma concentration is maintained above the MIC. Using the conventional administration method, there is a period during the entire surgical period in which the concentration decreases below the MIC unless redosing is performed. Taken together, it is necessary to develop a method for administering a prophylactic antibiotic to overcome these problems.
The target-controlled infusion (TCI) is a method of administering a drug while maintaining a target concentration and has been used for more than 20 years for administering hypnotic agents and opioids during general anesthesia. Because the infusion rate is continuously recalculated by an infusion algorithm mounted on the TCI infusion pump to maintain the target concentration, the infusion rate is not fixed and changes over time. The patient's specific characteristics such as body weight and creatinine clearance can be included in the pharmacokinetic parameters so that even when administered for the same duration and the same target concentration, the actual dosage varies for each patient and allows for personalized administration. Thus, the population pharmacokinetic parameters of a drug are required to administer the drug by the TCI method.
The risk of SSI varies depending on the type of surgery, and colorectal surgery is regarded as having a high risk of SSI because of the possibility of wound contamination from bowel contents. Accordingly, the incidence of SSI has been reported to be 4-10% in colon surgery and 3-27% in rectal surgery. In the case of colorectal surgery, the optimal prophylactic antibiotic has not been unified into one agent. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery.
The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function
- Conditions
- Anti-bacterial Agents, Pharmacokinetics, General Surgery
- Being tested
- target-controlled infusion (one of the administration methods), Standard administration method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
target-controlled infusion (one of the administration methods)Procedure or surgery
a method of administering cefoxitin while maintaining a constant target concentration.
Standard administration methodProcedure or surgery
Standard method of administering cefoxitin in the current clinical setting
| Study group | Role | What they receive |
|---|---|---|
| Standard administration method | Active comparator | Drug: Cefoxitin, Device: not applicable (standard method)
Two grams of cefoxitin (JW Pharmaceutical Co., Ltd., Seoul, South Korea) was dissolved in 50 mL of normal saline and administered for about 10 min before skin incision. Receives: Procedure: Standard administration method |
| Target controlled infusion (TCI) | Experimental | Drug: Cefoxitin, Device: TCI Syringe pump
Two grams of cefoxitin were dissolved in 50 mL of normal saline to give a concentration of 40 mg/mL. Before skin incision, cefoxitin was infused with a TCI syringe pump (Pilot Anesthesia 2, Fresenius vial, France), which was connected to a personal computer by an RS232c cable and controlled with TCI software (Asan pump, version 2.1.3; Bionet Co. Ltd., Seoul, Korea, http://www.fit4nm.org/download, last accessed: 27 August, 2012). Target concentrations of total concentrations were set to 80 μg/mL. Receives: Procedure: target-controlled infusion (one of the administration methods) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of surgical site infections
Surgical site infection (SSI) is an infection that occurs after surgery in the part of the body where the surgery took place. Superficial incisional SSI occurs just in the area of the skin where the incision was made. Deep incisional SSI occurs beneath the incision area in muscle and the tissues surrounding the muscles. Organ-space SSI includes infections involving any part of the anatomy that was opened or manipulated during an operation
Measured: Within 30 days after the operation
Secondary outcomes (1)
Total dose of cefoxitin
Total amount of cefoxitin administered as prophylactic antibiotics. Redosing is performed every two hours after the first dose.
Measured: on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start4 Apr 2022
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-bacterial AgentsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- When administering cefoxitin, the standard administration method and the target concentration control injection method are randomly assigned 1:1.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul Business Agency
- Responsible party
- Principal investigator, Byung-Moon Choi, Asan Medical Center
- Investigators
- Byung-Moon Choi, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253339
- Sponsor's protocol ID
- 2022-0180
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HJ, Kim KM, Lee JL, Park IJ, Choi BM. A single-centre randomised controlled trial comparing the standard method and target-controlled infusion as a method of administering cefoxitin, which is used to prevent surgical site infections in colorectal surgical patients: study protocol. Trials. 2025 Jan 8;26(1):11. doi: 10.1186/s13063-025-08716-x.
PubMed 39780190
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Trial Comparing the Standard Method and Target-controlled Infusion as a Method of Administering Cefoxitin, Which is Used to Prevent Surgical Site Infections in Colorectal Surgical Patients
- ClinicalTrials.gov ID
- NCT05253339
- Acronym / sponsor ID
- 2022-0180
- Conditions
- Anti-bacterial Agents, Pharmacokinetics, General Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,494 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul Business Agency
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 23 Feb 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.
Preoperative antimicrobial prophylaxis is a key element for the prevention of surgical site infection, the most common type of nosocomial infection in surgical patients. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery. Cefoxitin is generally dissolved in normal saline and intravenously administered for a short time of 5-10 minutes before skin incision. However, there are several drawbacks to the current dosing strategy. First, the dose of cefazolin is determined by a "rule of thumb", and there is controversy over whether 1 g or 2 g is appropriate, with the opinion that 2 g being more appropriate prevailing. Second, the standard administration method unnecessarily induces a concentration higher than the concentration required to prevent surgical site infection. Third, significant covariates that can affect the maintenance of MIC during surgery are not considered. The target-concentration controlled infusion (TCI) method can be a viable alternative administration method for antibiotics. The TCI method enables individual customized administration according to the covariates (i.e., weight, creatinine clearance) included in the pharmacokinetic parameters; also, although with some variability, the drug can be administered while maintaining the target concentration. The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function
Detailed description
Parenteral antimicrobial prophylaxis before abdominal surgery for preventing surgical site infection (SSI) is a well-established clinical practice. Prophylactic antibiotics are selected depending on the type of surgery, and first- or second-generation cephalosporins have been mainly used. These antibiotics are generally dissolved in normal saline and intravenously administered for a short time of 5-10 min before skin incision. However, the conventional administration strategy has several problems. First, the dose of antibiotics does not take into account the patients' physical characteristics such as body weight, age, and renal function. Considering that the dosages of practically all drugs used in clinical fields are determined based on body weight, it may be necessary to improve the dosing strategy to reflect the patient's physical characteristics based on the effectiveness and safety of the antibiotic. Second, the plasma concentration of cephalosporin becomes excessively high at the end of the administration, which is more pronounced in patients with low body weight. The minimal inhibitory concentrations (MIC) for each antibiotic are well-characterized; however, a pilot simulation study showed that at the end of the administration, the plasma concentration of cefazolin was 20 times higher than its MIC. It is difficult to exclude the possibility that concentrations higher than necessary may cause harm to patients. Third, the bactericidal activity of an antibiotic is apparent when its free plasma concentration is maintained above the MIC. Using the conventional administration method, there is a period during the entire surgical period in which the concentration decreases below the MIC unless redosing is performed. Taken together, it is necessary to develop a method for administering a prophylactic antibiotic to overcome these problems.
The target-controlled infusion (TCI) is a method of administering a drug while maintaining a target concentration and has been used for more than 20 years for administering hypnotic agents and opioids during general anesthesia. Because the infusion rate is continuously recalculated by an infusion algorithm mounted on the TCI infusion pump to maintain the target concentration, the infusion rate is not fixed and changes over time. The patient's specific characteristics such as body weight and creatinine clearance can be included in the pharmacokinetic parameters so that even when administered for the same duration and the same target concentration, the actual dosage varies for each patient and allows for personalized administration. Thus, the population pharmacokinetic parameters of a drug are required to administer the drug by the TCI method.
The risk of SSI varies depending on the type of surgery, and colorectal surgery is regarded as having a high risk of SSI because of the possibility of wound contamination from bowel contents. Accordingly, the incidence of SSI has been reported to be 4-10% in colon surgery and 3-27% in rectal surgery. In the case of colorectal surgery, the optimal prophylactic antibiotic has not been unified into one agent. Cefoxitin, a second-generation cephalosporin with anaerobic activity, has been used in various clinical settings as a prophylactic antibiotic for colorectal surgery.
The aim of this study was to evaluate the effectiveness of administering cefoxitin in patients undergoing colorectal surgery with a syringe pump equipped with a target concentration control injection function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- When administering cefoxitin, the standard administration method and the target concentration control injection method are randomly assigned 1:1.
| Arm | Type | Receives |
|---|---|---|
| Standard administration method | Active comparator | Procedure: Standard administration methodDrug: Cefoxitin, Device: not applicable (standard method) Two grams of cefoxitin (JW Pharmaceutical Co., Ltd., Seoul, South Korea) was dissolved in 50 mL of normal saline and administered for about 10 min before skin incision. |
| Target controlled infusion (TCI) | Experimental | Procedure: target-controlled infusion (one of the administration methods)Drug: Cefoxitin, Device: TCI Syringe pump Two grams of cefoxitin were dissolved in 50 mL of normal saline to give a concentration of 40 mg/mL. Before skin incision, cefoxitin was infused with a TCI syringe pump (Pilot Anesthesia 2, Fresenius vial, France), which was connected to a personal computer by an RS232c cable and controlled with TCI software (Asan pump, version 2.1.3; Bionet Co. Ltd., Seoul, Korea, http://www.fit4nm.org/download, last accessed: 27 August, 2012). Target concentrations of total concentrations were set to 80 μg/mL. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 20 years old
- Patients who are scheduled to undergo colon or rectal surgery
- Patients scheduled to receive cefoxitin as a prophylactic antibiotic
Key exclusion criteria (4 listed)
- Known allergies, hypersensitivity, or intolerance to cefoxitin
- Patients with a history of receiving cefoxitin within 3 days of the scheduled surgery time
- Patients receiving therapeutic antibiotics
- eGFR < 30 ml/min/1.73m2
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 |
|---|---|---|
| target-controlled infusion (one of the administration methods)a method of administering cefoxitin while maintaining a constant target concentration. | Procedure or surgery | Target controlled infusion (TCI) |
| Standard administration methodStandard method of administering cefoxitin in the current clinical setting | Procedure or surgery | Standard administration method |
Primary outcome
The incidence of surgical site infections
Time frame: Within 30 days after the operation
Surgical site infection (SSI) is an infection that occurs after surgery in the part of the body where the surgery took place. Superficial incisional SSI occurs just in the area of the skin where the incision was made. Deep incisional SSI occurs beneath the incision area in muscle and the tissues surrounding the muscles. Organ-space SSI includes infections involving any part of the anatomy that was opened or manipulated during an operation
1 secondary outcome
Total dose of cefoxitin
Time frame: on the day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 39780190Kim HJ, Kim KM, Lee JL, Park IJ, Choi BM. A single-centre randomised controlled trial comparing the standard method and target-controlled infusion as a method of administering cefoxitin, which is used to prevent surgical site infections in colorectal surgical patients: study protocol. Trials. 2025 Jan 8;26(1):11. doi: 10.1186/s13063-025-08716-x.
- 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.
Byung-Moon Choi, Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard administration method in people with Anti-bacterial Agents and Pharmacokinetics, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 4 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 25 Sep 2025. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of surgical site infections (time frame: Within 30 days after the operation). 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 NCT05253339, 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 25 Sep 2025.