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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03310606

Collaborator

(none)

Enrollment

Location

Arm

18.2

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peritonitis Critical Illness	Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 24, 2017

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum and peritoneal beta lactams concentrations at 3 times [3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU]
Population : patients with surgical peritonitis. The concentrations are compared with the minimum inhibitory concentrations of bacteria to diagnose a sub therapeutic dosage.

Secondary Outcome Measures

Factors associated with an antibiotic under-dosage [Statistical analysis after 2 years of inclusion]
effect of presence of septic shock on antibiotic concentration
Factors associated with an antibiotic under-dosage [Statistical analysis after 2 years of inclusion]
effect of volume ressucitation on antibiotic concentration
Factors associated with an antibiotic under-dosage [Statistical analysis after 2 years of inclusion]
effect of renal function on antibiotic concentration
Evaluate the relationship between serum and peritoneal concentrations of beta-lactam [Statistical analysis after 2 years of inclusion]
Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam
Morbidity of included patients [Reception on the 8th postoperative day]
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)
Mortality of included patients [Reception on the 8th postoperative day]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Hospital	Vandoeuvre les Nancy		France	54500

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Principal Investigator: Emmanuel NOVY, MD, CHRU NANCY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT03310606

Other Study ID Numbers:

2017-A00710-53

First Posted:

Oct 16, 2017

Last Update Posted:

Jan 18, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Central Hospital, Nancy, France

Therapeutic drug monitoring

Additional relevant MeSH terms:

Peritonitis

Critical Illness

Anti-Bacterial Agents

Lactams

Study Results

No Results Posted as of Jan 18, 2019