ClinicalTrials.Veeva

Menu

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

C

Central Hospital, Nancy, France

Status

Unknown

Conditions

Peritonitis
Critical Illness

Treatments

Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03310606
2017-A00710-53

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Peritonitis
Other group
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
Treatment:
Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment

Trial contacts and locations

1

Loading...

Central trial contact

Emmanuel NOVY, MD; El Mehdi SIAGHY

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems