Antibiotic Prophylaxis SurgeryPhase 4PROPHYLOXITINENCT02703857
Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
A Phase 4 study testing cefoxitin in people with Antibiotic Prophylaxis Surgery, run by Poitiers University Hospital at 1 site in France.
Trial summary
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibiotic Prophylaxis Surgery
- What is being tested?
- cefoxitin
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 20 Sep 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin
Who cannot join
- morbid obesity (BMI > 35 kg/m²)
- severe renal impairment (clearance creatinine < 30ml/min)
- beta lactam hypersensitivity
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
Read more
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
- Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
- Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
- Urinary concentrations of cefoxitin
- Conditions
- Antibiotic Prophylaxis Surgery
- Being tested
- cefoxitin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefoxitinDrug
Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and free plasma of cefoxitin after repeated injections
Measured: 48 hours
Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections
Measured: 48 hours
Concentration of cefoxitin in urine after every injection
Measured: 48 hours
Secondary outcomes (7)
Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms
Measured: 48 hours
Concentrations of antibiotic in peritoneal fluid
Measured: 48 hours
Clearance of distribution of cefoxitin
Measured: 48 hours
Clearance of elimination of cefoxitin
Measured: 48 hours
Cmax of Cefoxitin
Measured: 48 hours
Vd of distribution o cefoxitin
Measured: 48 hours
Area under the curve of plasma and tissue concentration of cefoxitin
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completion15 Sep 2016
- Study completion20 Sep 2016
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 Antibiotic Prophylaxis SurgeryStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703857
- Sponsor's protocol ID
- PROPHYLOXITINE
- Acronym
- PROPHYLOXITINE
- Status last verified
- Jun 2017
- First submitted
- 9 Feb 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
Publications
Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.
PubMed 31220258
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
- ClinicalTrials.gov ID
- NCT02703857
- Acronym / sponsor ID
- PROPHYLOXITINE / PROPHYLOXITINE
- Conditions
- Antibiotic Prophylaxis Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 20 Sep 2016
- First posted
- 9 Mar 2016 (estimated)
- 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.
The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.
The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.
This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.
They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.
The primary endpoints are:
- Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
- Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
- Urinary concentrations of cefoxitin
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin
Key exclusion criteria (4 listed)
- morbid obesity (BMI > 35 kg/m²)
- severe renal impairment (clearance creatinine < 30ml/min)
- beta lactam hypersensitivity
- pregnancy
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 |
|---|---|---|
| cefoxitinParenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing | Drug | – |
Primary outcome
Total and free plasma of cefoxitin after repeated injections
Time frame: 48 hours
Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections
Time frame: 48 hours
Concentration of cefoxitin in urine after every injection
Time frame: 48 hours
7 secondary outcomes
Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms
Time frame: 48 hours
Concentrations of antibiotic in peritoneal fluid
Time frame: 48 hours
Clearance of distribution of cefoxitin
Time frame: 48 hours
Clearance of elimination of cefoxitin
Time frame: 48 hours
Cmax of Cefoxitin
Time frame: 48 hours
Vd of distribution o cefoxitin
Time frame: 48 hours
Area under the curve of plasma and tissue concentration of cefoxitin
Time frame: 48 hours
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 12 Jun 2017.
- Derived from this study: PubMed 31220258Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.
Related trials for Antibiotic Prophylaxis Surgery
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
RecruitingPhase 3
Prophylactic Antibiotic Duration in Head and Neck Cancer Surgery (PROTECT-HN Trial)
Surgical Wound Infection, Head and Neck Neoplasms
RecruitingObservational study
Perioperative Pharmacokinetic/Pharmacodynamic Target Attainment of Piperacillin During Major Hepatic and Pancreatic Surgery
Antibiotic Prophylaxis, Pancreatic Surgey
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefoxitin in people with Antibiotic Prophylaxis Surgery, run by Poitiers University Hospital 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 1 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 12 Jun 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total and free plasma of cefoxitin after repeated injections (time frame: 48 hours). The study lists 3 primary outcomes in all. 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 NCT02703857, 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 12 Jun 2017.