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Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis (SPAC)

Primary Purpose

Peritonitis, Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dosage of serum and peritoneal of the B lactam used for antibiotic treatment
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peritonitis focused on measuring Therapeutic drug monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Minimun age limits 18 years
  • All sex
  • Patients with peritonitis (community or nosocomial) regardless of pathology involved
  • Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard)

Exclusion Criteria:

  • Beta lactam allergy
  • Pregnancy
  • Age less than 18 years
  • No respect of recommandations for antibiotics ( molecule and dosage)
  • Person under legal protection

Sites / Locations

  • Central HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Peritonitis

Arm Description

Patient received for antibiotic treatment a B lactam according to French recommendation : type of antibiotic : cefotaxime or ceftriaxone or piperacilline/tazobactam or imipenem dose : cefotaxime 2g / cetriaxone 2g / piperacilline 4g / imipenem 1g

Outcomes

Primary Outcome Measures

Serum and peritoneal beta lactams concentrations at 3 times
Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage.

Secondary Outcome Measures

Factors associated with an antibiotic under-dosage
effect of presence of septic shock on antibiotic concentration
Factors associated with an antibiotic under-dosage
effect of volume ressucitation on antibiotic concentration
Factors associated with an antibiotic under-dosage
effect of renal function on antibiotic concentration
Evaluate the relationship between serum and peritoneal concentrations of beta-lactam
Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam
Morbidity of included patients
Morbidity is assessed by the presence or absence of second peritonitis surgery during hospitalization in ICU and at most 8 days (the mean of the peritonitis stays in the ICU of the investigators in 2016 is 8 days)
Mortality of included patients
The mortality is evaluated by the presence or absence of the death of the patient during the hospitalization in ICU and at most 8 days

Full Information

First Posted
August 28, 2017
Last Updated
January 17, 2019
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03310606
Brief Title
Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis
Acronym
SPAC
Official Title
Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
SPAC is a pilote monocentric prospective study about peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will included 50 patients during 2 years in the University Hospital of Nancy. The aim of this study is to determine if the beta-lactam dosages recommended by the guidelines for management of intra-abdominal infections (published by the Société française d'anesthésie et de réanimation (Sfar) in december 2015) permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis. The investigators will collected 3 pairs of serum and peritoneal fluid samples at 3 different times: peritoneal incision, arrival in ICU and 24 hours after admission in ICU in order to compare the concentrations and the minimal inhibitor concentration of bacteria. The hypothesis is that of a serum and peritoneal antibiotic under dosage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonitis, Critical Illness
Keywords
Therapeutic drug monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peritonitis
Arm Type
Other
Arm Description
Patient received for antibiotic treatment a B lactam according to French recommendation : type of antibiotic : cefotaxime or ceftriaxone or piperacilline/tazobactam or imipenem dose : cefotaxime 2g / cetriaxone 2g / piperacilline 4g / imipenem 1g
Intervention Type
Other
Intervention Name(s)
Dosage of serum and peritoneal of the B lactam used for antibiotic treatment
Intervention Description
Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM
Primary Outcome Measure Information:
Title
Serum and peritoneal beta lactams concentrations at 3 times
Description
Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage.
Time Frame
3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU
Secondary Outcome Measure Information:
Title
Factors associated with an antibiotic under-dosage
Description
effect of presence of septic shock on antibiotic concentration
Time Frame
Statistical analysis after 2 years of inclusion
Title
Factors associated with an antibiotic under-dosage
Description
effect of volume ressucitation on antibiotic concentration
Time Frame
Statistical analysis after 2 years of inclusion
Title
Factors associated with an antibiotic under-dosage
Description
effect of renal function on antibiotic concentration
Time Frame
Statistical analysis after 2 years of inclusion
Title
Evaluate the relationship between serum and peritoneal concentrations of beta-lactam
Description
Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam
Time Frame
Statistical analysis after 2 years of inclusion
Title
Morbidity of included patients
Description
Morbidity is assessed by the presence or absence of second peritonitis surgery during hospitalization in ICU and at most 8 days (the mean of the peritonitis stays in the ICU of the investigators in 2016 is 8 days)
Time Frame
Reception on the 8th postoperative day
Title
Mortality of included patients
Description
The mortality is evaluated by the presence or absence of the death of the patient during the hospitalization in ICU and at most 8 days
Time Frame
Reception on the 8th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Minimun age limits 18 years All sex Patients with peritonitis (community or nosocomial) regardless of pathology involved Patients treated in the Universty Hospital of Vandoeuvre les Nancy (abdominal surgery unit and surgical Intensive care unit JM Picard) Exclusion Criteria: Beta lactam allergy Pregnancy Age less than 18 years No respect of recommandations for antibiotics ( molecule and dosage) Person under legal protection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel NOVY, MD
Phone
+33 3157437
Email
e.novy@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
El Mehdi SIAGHY
Phone
+33 3155276
Email
m.siaghy@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel NOVY, MD
Organizational Affiliation
CHRU NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel NOVY, MD
Phone
+33 383157437
Email
e.novy@chru-nancy.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
31599951
Citation
Leon L, Guerci P, Pape E, Thilly N, Luc A, Germain A, Butin-Druoton AL, Losser MR, Birckener J, Scala-Bertola J, Novy E. Serum and peritoneal exudate concentrations after high doses of beta-lactams in critically ill patients with severe intra-abdominal infections: an observational prospective study. J Antimicrob Chemother. 2020 Jan 1;75(1):156-161. doi: 10.1093/jac/dkz407.
Results Reference
derived

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Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis

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