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

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

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Peritonitis
• Intervention / Treatment: Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel NOVY, MD; Phone Number: +33 3157437; Email: e.novy@chru-nancy.fr
• Study Contact Backup: Name: El Mehdi SIAGHY; Phone Number: +33 3155276; Email: m.siaghy@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre les Nancy, France, 54500
    • Recruiting
    • Central Hospital
    • Contact: Emmanuel NOVY, MD; Phone Number: +33 383157437; Email: e.novy@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Peritonitis; 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	Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment; Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with an antibiotic under-dosage	effect of presence of septic shock on antibiotic concentration	Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage	effect of volume ressucitation on antibiotic concentration	Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage	effect of renal function on antibiotic concentration	Statistical analysis after 2 years of inclusion
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	Statistical analysis after 2 years of inclusion
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)	Reception on the 8th postoperative day
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	Reception on the 8th postoperative day

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Emmanuel NOVY, MD, CHRU Nancy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Therapeutic drug monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Disease Attributes; Intraabdominal Infections; Critical Illness; Peritonitis; Anti-Infective Agents; Anti-Bacterial Agents; Lactams
• Other Study ID Numbers: 2017-A00710-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No