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

NCT ID: NCT03310606

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2019-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Peritonitis Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel NOVY, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU NANCY

Locations

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Central Hospital

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emmanuel NOVY, MD

Role: CONTACT

+33 3157437

El Mehdi SIAGHY

Role: CONTACT

+33 3155276

Facility Contacts

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Emmanuel NOVY, MD

Role: primary

+33 383157437

References

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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.

Reference Type DERIVED
PMID: 31599951 (View on PubMed)

Other Identifiers

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2017-A00710-53

Identifier Type: -

Identifier Source: org_study_id

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