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Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique (PROPHYLOXITINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02703857
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief 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. 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

Condition or disease Intervention/treatment Phase
Antibiotic Prophylaxis Surgery Drug: cefoxitin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Study Start Date : February 2016
Actual Primary Completion Date : September 15, 2016
Study Completion Date : September 20, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: cefoxitin
    Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing


Primary Outcome Measures :
  1. Total and free plasma of cefoxitin after repeated injections [ Time Frame: 48 hours ]
  2. Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections [ Time Frame: 48 hours ]
  3. Concentration of cefoxitin in urine after every injection [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms [ Time Frame: 48 hours ]
  2. Concentrations of antibiotic in peritoneal fluid [ Time Frame: 48 hours ]
  3. Clearance of distribution of cefoxitin [ Time Frame: 48 hours ]
  4. Clearance of elimination of cefoxitin [ Time Frame: 48 hours ]
  5. Cmax of Cefoxitin [ Time Frame: 48 hours ]
  6. Vd of distribution o cefoxitin [ Time Frame: 48 hours ]
  7. Area under the curve of plasma and tissue concentration of cefoxitin [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

Exclusion Criteria:

  • morbid obesity (BMI > 35 kg/m²)
  • severe renal impairment (clearance creatinine < 30ml/min)
  • beta lactam hypersensitivity
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703857


Locations
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France
Centre Hospitalier de Poitiers
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02703857    
Other Study ID Numbers: PROPHYLOXITINE
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Cefoxitin
Cefotaxime
Anti-Bacterial Agents
Anti-Infective Agents