PeritonitisSPACNCT03310606
Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis
A study testing Dosage of serum and peritoneal of the B lactam used for antibiotic treatment in people with Peritonitis and Critical Illness, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis, Critical Illness
- What is being tested?
- Dosage of serum and peritoneal of the B lactam used for antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Beta lactam allergy
- Pregnancy
- Age less than 18 years
- No respect of recommandations for antibiotics ( molecule and dosage)
- Person under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Central Hospital
Vandœuvre-lès-Nancy, 54500
Emmanuel NOVY, MD, +33 383157437, e.novy@chru-nancy.fr
About this study
Official title: Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC
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.
Read more
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.
- Conditions
- Peritonitis, Critical Illness
- Being tested
- Dosage of serum and peritoneal of the B lactam used for antibiotic treatment
- Keywords
- Therapeutic drug monitoring
- Medical subject headings
- Peritonitis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU
Secondary outcomes (6)
Factors associated with an antibiotic under-dosage
effect of presence of septic shock on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
effect of volume ressucitation on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
effect of renal function on antibiotic concentration
Measured: Statistical analysis after 2 years of inclusion
Evaluate the relationship between serum and peritoneal concentrations of beta-lactam
Determination of the antibiotic diffusion coefficient through the peritoneal membrane : difference between serum concentration and peritoneal concentration of B lactam
Measured: Statistical analysis after 2 years of inclusion
Morbidity of included patients
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)
Measured: Reception on the 8th postoperative day
Mortality of included patients
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
Measured: Reception on the 8th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start24 Oct 2017
- Primary completion1 Mar 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel NOVY, MD, Principal investigator, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310606
- Sponsor's protocol ID
- 2017-A00710-53
- Acronym
- SPAC
- Status last verified
- Jan 2019
- First submitted
- 28 Aug 2017
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31599951
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Peritoneal Concentration in Antibiotics During the Surgical Management of Peritonitis: SPAC
- ClinicalTrials.gov ID
- NCT03310606
- Acronym / sponsor ID
- SPAC / 2017-A00710-53
- Conditions
- Peritonitis, Critical Illness
- Keywords
- Therapeutic drug monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peritonitis | Other | Other: Dosage of serum and peritoneal of the B lactam used for antibiotic treatmentPatient 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- Beta lactam allergy
- Pregnancy
- Age less than 18 years
- No respect of recommandations for antibiotics ( molecule and dosage)
- Person under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dosage of serum and peritoneal of the B lactam used for antibiotic treatmentDosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM | Other | Peritonitis |
Primary outcome
Serum and peritoneal beta lactams concentrations at 3 times
Time frame: 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.
6 secondary outcomes
Factors associated with an antibiotic under-dosage
Time frame: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
Time frame: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
Time frame: Statistical analysis after 2 years of inclusion
Evaluate the relationship between serum and peritoneal concentrations of beta-lactam
Time frame: Statistical analysis after 2 years of inclusion
Morbidity of included patients
Time frame: Reception on the 8th postoperative day
Mortality of included patients
Time frame: Reception on the 8th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 31599951Leon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel NOVY, MD principal investigator
CHRU NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of serum and peritoneal of the B lactam used for antibiotic treatment in people with Peritonitis and Critical Illness, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel NOVY, MD (+33 3157437, e.novy@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum and peritoneal beta lactams concentrations at 3 times (time frame: 3 times : Peritoneal incision, Admission in ICU and 24 hours after admission in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.