ObeseCEFOBARNCT03306290
Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery
A study testing Serum dosage of antibiotic prophylaxis CEFOXITIN in people with Obese and Antibiotic Prophylaxis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obese, Antibiotic Prophylaxis, Bariatric Surgery Candidate
- What is being tested?
- Serum dosage of antibiotic prophylaxis CEFOXITIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2017to 9 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years-old,
- Severely obese patient with a BMI ≥ 35 kg.m-2,
- Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy,
- Affiliated to social security,
- The patient is able to consent to clinical research and has received all information on the study design/protocol,
- Signed/written informed consent
Who cannot join
- Refuse to consent to the study or the patient is unable to consent,
- Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected,
- Pregnancy,
- Persons deprived of their liberty by judicial or administrative decision,
- Urgent or emergent surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Severely and Morbidly Obese Patients Undergoing BARiatric Surgery (CEFOBAR)
Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.
Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.
The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.
- Conditions
- Obese, Antibiotic Prophylaxis, Bariatric Surgery Candidate
- Being tested
- Serum dosage of antibiotic prophylaxis CEFOXITIN
- Keywords
- Obese, Bariatric surgery, Antibiotic prophylaxis, Cefoxitin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum dosage of antibiotic prophylaxis CEFOXITINDrug
Also called Drug dosage
Three blood samples will be collected. These samples are specific for the research, and will be performed on the forearm opposite to the one used for Cefoxitin infusion.
- Blood sample at the start of surgery (t0): at the end of the Cefoxitin infusion (~30 min), 1 tube (5 ml) of blood will be withdrawn
- Blood sample at half way surgery (t1): 1 tube (5 ml) of blood will be withdrawn (if applicable)
- Blood sample at skin closure (t2): 1 tube (5 ml) of blood will be withdrawn
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery candidate | Other | Patients included in this study belong to this arm and put up with intervention "Serum dosage of antibiotic prophylaxis CEFOXITIN" Receives: Drug: Serum dosage of antibiotic prophylaxis CEFOXITIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of Cefoxitin at the beginning and end of the surgery with one extra measurement at halfway surgery
Blood samples will be put at low temperature for transportation and then analysed by chromatographic method
Measured: baseline
Secondary outcomes (12)
Identification of factors that may be associated with the risk of under-dosage
effect of creatinine clearance on cefoxitine concentration
Measured: baseline
Identification of factors that may be associated with the risk of under-dosage
effect of age of the patient on cefoxitine concentration
Measured: baseline
Identification of factors that may be associated with the risk of under-dosage
effect of lenght of surgery on cefoxitine concentration
Measured: baseline
Identification of factors that may be associated with the risk of under-dosage
effect of type of surgery on cefoxitine concentration
Measured: baseline
Pharmacokinetic parameters: drug clearance
These parameters will be calculated according to the initial concentration (C0) and the final concentration (C2) measured at t0 and t2 respectively. A corrective factor will be applied according to the halfway surgery serum concentration of Cefoxitin.
- Clearance: Cl=k x Vd
Measured: baseline
Pharmacokinetic parameter: volume of distribution
This parameter will be calculated according to the initial concentration (C0) and the final concentration (C2) measured at t0 and t2 respectively. A corrective factor will be applied according to the halfway surgery serum concentration of Cefoxitin.
- Volume of distribution: D0/C0
Measured: baseline
Pharmacokinetic parameter: half-life
This parameter will be calculated according to the initial concentration (C0) and the final concentration (C2) measured at t0 and t2 respectively. A corrective factor will be applied according to the halfway surgery serum concentration of Cefoxitin.
- Half-life: t1/2=ln2/k
Measured: baseline
Pharmacokinetic parameter: area under curve,
This parameter will be calculated according to the initial concentration (C0) and the final concentration (C2) measured at t0 and t2 respectively. A corrective factor will be applied according to the halfway surgery serum concentration of Cefoxitin.
- Area under curve: AUC=C0/k
Measured: baseline
Pharmacokinetic parameter: elimination rate
This parameter will be calculated according to the initial concentration (C0) and the final concentration (C2) measured at t0 and t2 respectively. A corrective factor will be applied according to the halfway surgery serum concentration of Cefoxitin.
- Elimination rate: k=(LnC0-LnC2)/(t2-t0)
Measured: baseline
Incidence of superficial incisional surgical site infection (SSI) at 30 days
- Superficial incisional SSI: at 30 days defined by:
Date of event for infection occurs within 30 days after any operative procedure AND involves only skin and subcutaneous tissue of the incision AND the patient has at least one of the following:
- purulent drainage from the superficial incision,
- organisms identified from an aseptically-obtained specimen,
- from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (e.g., not Active Surveillance Culture/Testing (ASC/AST),
- superficial incision that is deliberately opened by a surgeon, attending physician or other designee and culture or non-culture based testing is not performed AND patient has at least one of the following signs or symptoms: pain or tenderness;localized swelling; erythema; or heat,
- diagnosis of a superficial incisional SSI by the surgeon or attending physician or other designee.
Measured: up to 30 days after surgery
Incidence of deep incisional surgical site infection (SSI) at 30 days
Deep incisional SSI at 30 days defined by:
date of event for infection occurs within 30 days after the operative procedure AND involves deep soft tissues of the incision (e.g., fascial and muscle layers) AND patient has at least one of the following:
- purulent drainage from the deep incision,
- a deep incision that spontaneously dehisces, or is deliberately opened or aspirated by a surgeon, attending physician or other designee and organism is identified by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment (e.g., not Active Surveillance Culture/Testing (ASC/AST) or culture or non-culture based microbiologic testing method is not performed AND patient has at least one of the following signs or symptoms: fever (>38°C); localized pain or tenderness.
- an abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
Measured: up to 30 days after surgery
Incidence of organ/space surgical site infection (SSI) at 30 days
Organ/Space SSI at 30 days defined by:
Date of event for infection occurs within 30 after the operative procedure AND infection involves any part of the body deeper than the fascial/muscle layers, that is opened or manipulated during the operative procedure AND patient has at least one of the following:
- purulent drainage from a drain that is placed into the organ/space
- organisms are identified from an fluid or tissue in the organ/space by a culture or non-culture based microbiologic testing method
- an abscess or other evidence of infection involving the organ/space that is detected on gross anatomical or histopathologic exam, or imaging test evidence suggestive of infection AND meets at least one criterion for a specific organ/space infection site listed: intraabdominal infection, not specified elsewhere including gallbladder, bile ducts, liver, spleen, pancreas, peritoneum, subphrenic or subdiaphragmatic space
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start30 Oct 2017
- Primary completion30 Jun 2018
- Study completion9 Aug 2018
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 ObeseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El Mehdi SIAGHY, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306290
- Sponsor's protocol ID
- 2017-A01285-48
- Acronym
- CEFOBAR
- Status last verified
- Jul 2018
- First submitted
- 28 Aug 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Novy E, Liu X, Hernandez-Mitre MP, Belveyre T, Scala-Bertola J, Roberts JA, Parker SL. Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study. Anaesth Crit Care Pain Med. 2024 Jun;43(3):101376. doi: 10.1016/j.accpm.2024.101376. Epub 2024 Mar 15.
PubMed 38494157
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Severely and Morbidly Obese Patients Undergoing BARiatric Surgery (CEFOBAR)
- ClinicalTrials.gov ID
- NCT03306290
- Acronym / sponsor ID
- CEFOBAR / 2017-A01285-48
- Conditions
- Obese, Antibiotic Prophylaxis, Bariatric Surgery Candidate
- Keywords
- Obese, Bariatric surgery, Antibiotic prophylaxis, Cefoxitin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 11 Oct 2017 (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.
Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.
Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.
The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery candidate | Other | Drug: Serum dosage of antibiotic prophylaxis CEFOXITINPatients included in this study belong to this arm and put up with intervention "Serum dosage of antibiotic prophylaxis CEFOXITIN" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years-old,
- Severely obese patient with a BMI ≥ 35 kg.m-2,
- Scheduled bariatric surgery: gastric by-pass or sleeve gastrectomy,
- Affiliated to social security,
- The patient is able to consent to clinical research and has received all information on the study design/protocol,
Key exclusion criteria (5 listed)
- Refuse to consent to the study or the patient is unable to consent,
- Allergy/Anaphylaxis to beta-lactam (ß-lactam) antibiotics either proven or suspected,
- Pregnancy,
- Persons deprived of their liberty by judicial or administrative decision,
- Urgent or emergent surgery.
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 |
|---|---|---|
| Serum dosage of antibiotic prophylaxis CEFOXITINAlso: Drug dosageThree blood samples will be collected. These samples are specific for the research, and will be performed on the forearm opposite to the one used for Cefoxitin infusion. 1. Blood sample at the start of surgery (t0): at the end of the Cefoxitin infusion (~30 min), 1 tube (5 ml) of blood will be withdrawn 2. Blood sample at half way surgery (t1): 1 tube (5 ml) of blood will be withdrawn (if applicable) 3. Blood sample at skin closure (t2): 1 tube (5 ml) of blood will be withdrawn | Drug | Bariatric surgery candidate |
Primary outcome
Serum concentration of Cefoxitin at the beginning and end of the surgery with one extra measurement at halfway surgery
Time frame: baseline
Blood samples will be put at low temperature for transportation and then analysed by chromatographic method
12 secondary outcomes
Identification of factors that may be associated with the risk of under-dosage
Time frame: baseline
Identification of factors that may be associated with the risk of under-dosage
Time frame: baseline
Identification of factors that may be associated with the risk of under-dosage
Time frame: baseline
Identification of factors that may be associated with the risk of under-dosage
Time frame: baseline
Pharmacokinetic parameters: drug clearance
Time frame: baseline
Pharmacokinetic parameter: volume of distribution
Time frame: baseline
Pharmacokinetic parameter: half-life
Time frame: baseline
Pharmacokinetic parameter: area under curve,
Time frame: baseline
Pharmacokinetic parameter: elimination rate
Time frame: baseline
Incidence of superficial incisional surgical site infection (SSI) at 30 days
Time frame: up to 30 days after surgery
Incidence of deep incisional surgical site infection (SSI) at 30 days
Time frame: up to 30 days after surgery
Incidence of organ/space surgical site infection (SSI) at 30 days
Time frame: up to 30 days after 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 28 Aug 2018.
- Derived from this study: PubMed 38494157Novy E, Liu X, Hernandez-Mitre MP, Belveyre T, Scala-Bertola J, Roberts JA, Parker SL. Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study. Anaesth Crit Care Pain Med. 2024 Jun;43(3):101376. doi: 10.1016/j.accpm.2024.101376. Epub 2024 Mar 15.
- 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.
El Mehdi SIAGHY study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum dosage of antibiotic prophylaxis CEFOXITIN in people with Obese and Antibiotic Prophylaxis, run by Central Hospital, Nancy, France at 1 site in France.
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 6 inclusion and 5 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 28 Aug 2018. 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 France. 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?
Serum concentration of Cefoxitin at the beginning and end of the surgery with one extra measurement at halfway surgery (time frame: baseline). 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 NCT03306290, 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 28 Aug 2018.