NCT03310606

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

August 28, 2017

Last Update Submit

January 17, 2019

Conditions

PeritonitisCritical Illness

Keywords

Therapeutic drug monitoring

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Factors associated with an antibiotic under-dosage

    Statistical analysis after 2 years of inclusion

  • Factors associated with an antibiotic under-dosage

    Statistical analysis after 2 years of inclusion

  • Factors associated with an antibiotic under-dosage

    Statistical analysis after 2 years of inclusion

  • Evaluate the relationship between serum and peritoneal concentrations of beta-lactam

    Statistical analysis after 2 years of inclusion

  • Morbidity of included patients

    Reception on the 8th postoperative day

  • +1 more secondary outcomes

Study Arms (1)

Peritonitis

OTHER

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

Interventions

Dosage of serum and peritoneal of the B lactam used for antibiotic treatmentOTHER

Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM

Peritonitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31599951DERIVED

MeSH Terms

Conditions

PeritonitisCritical Illness

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emmanuel NOVY, MD

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel NOVY, MD

CONTACT

+33 3157437e.novy@chru-nancy.fr

El Mehdi SIAGHY

CONTACT

+33 3155276m.siaghy@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

October 16, 2017

Study Start

October 24, 2017

Primary Completion

March 1, 2019

Study Completion

May 1, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Locations

FR(1)