Clinical trial NCT03310606: Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis
Official title: Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritonitis
Critical Illness
Keywords: Therapeutic drug monitoring
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Serum and peritoneal beta lactams concentrations at 3 times
timeFrame: 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU
Secondary outcomes:
measure: Factors associated with an antibiotic under-dosage
timeFrame: Statistical analysis after 2 years of inclusion
measure: Factors associated with an antibiotic under-dosage
timeFrame: Statistical analysis after 2 years of inclusion
measure: Factors associated with an antibiotic under-dosage
timeFrame: Statistical analysis after 2 years of inclusion
measure: Evaluate the relationship between serum and peritoneal concentrations of beta-lactam
timeFrame: Statistical analysis after 2 years of inclusion
measure: Morbidity of included patients
timeFrame: Reception on the 8th postoperative day
measure: Mortality of included patients
timeFrame: Reception on the 8th postoperative day
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: Central Hospital
Study officials:
affiliation: CHRU NANCY
name: Emmanuel NOVY, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.