PeritonitisDIFFUPERPEDNCT05308849
Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis
A study testing Dosage of serum and peritoneal of the betalactam used for antibiotic treatment in people with Peritonitis and Appendicitis, run by Central Hospital, Nancy, France.
Trial summary
This is a pilote monocentric prospective study about pediatric peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will include 41 patients between 3 and 17 years-old during 2 years in the University Hospital of Nancy. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Peritonitis, Appendicitis, Children, Only
- What is being tested?
- Dosage of serum and peritoneal of the betalactam used for antibiotic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2022to 30 Jun 2024
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosis of intra-abdominal infection : localized or generalized peritonitis secondary to appendix
Who cannot join
- betalactams allergy
- peritonitis with other etiology than appendix
- antibiotic treatment longer than 24h
About this study
This is a pilote monocentric prospective study about pediatric peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will include 41 patients between 3 and 17 years-old during 2 years in the University Hospital of Nancy.
The aim of this study is to determine if the beta-lactam dosages in children recommended by the guidelines for management of intra-abdominal infections permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.
Read more
The investigators will collected serum and peritoneal fluid samples at 3 different times: peritoneal incision, end of surgery, 2 days and 5 days after surgery 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.
Read the detailed description
Pediatric population with localized or generalized appendicular peritonitis with surgical management at the Nancy University Hospital.
Patients are usually taken in emergency at the Pediatric Emergency Department (Children's Hospital, CHRU Nancy). The diagnosis of peritonitis is then made or confirmed by clinical examination and paraclinical tests (biology and imaging).
Written informed consent is obtained from one of the parental authority holders, allowing inclusion in the study. An information document adapted to the child's understanding will also be sent to him/her. The child's non-opposition will be sought if he/she is old enough to understand. The information will be given jointly to the child and to the legal guardians present at the patient's bed at the time of diagnosis of peritonitis. The reflection period will correspond to the interval between this information and the management in the operating room. This may vary depending on the occupation of the operating room.
The diagnosis of appendicular peritonitis is made by the surgeon (routine care). The child is included.
Antibiotic therapy is started IV according to the protocol in force at the CHRU (routine care):
- Cefotaxime (200 mg/kg/d, 4 IV administrations) + Metronidazole (20-30 mg/kg/d, 3 IV administrations)+/-Gentamicin (3-8 mg/kg/d IV)
Specific biological samples and collections are taken for the research:
- A blood sample (1mL) (S0) after injection of the antibiotic and before appendicular section, non-invasive because performed on peripheral venous route.
- A blood sample (1mL) (S1) at the end of the operation, either when the peripheral venous route is placed if possible (non-invasive), otherwise at the periphery (invasive).
- If a drainage of the peritoneal cavity is in place, a non-invasive collection of peritoneal fluid (5 mL) on the drain will be performed (P1) at D2.
- If generalized peritonitis, an additional blood collection (1mL) at D5 (S2) during the biological check-up (routine care). If an abdominal drainage is still in place, a non-invasive collection of peritoneal fluid (5mL) on drain will be performed (P2). At D5, the patients are under appropriate antibiotic therapy.
Specifically for research, betalactam assays are performed on S0, S1, S2, P0, P1 and P2 once all samples have been sent to Pharmacology.
Bacteriological analyses are performed on P0 (routine care), P1 and P2 in real time.
The following specific data will be collected: time of first antibiotic administration, time of sampling (S0, S1 and P0), time of surgery start. Data concerning antibiotic therapy (dosage, frequency of administration) will be collected during the entire hospitalization period as well as the time of the other samples if applicable (S2, P1 and P2).
Clinical and biological data are collected, including the visit at 4-6 weeks after discharge. (In routine care, a visit at 1 month post-op is performed). The investigator looks for AEs or SAEs. At the end of this post-operative visit, the patient is discharged from the study.
The volume of blood collected in the framework of the research is estimated at 3mL, i.e. less than 2.5% of the total blood volume over the inclusion period. The maximum total volume collected is 24 mL (6 mL for research, 18 mL for care, i.e. 3 samples of CBC, blood ionogram and CRP).
Blood and peritoneal samples :
The 3 blood samples as well as the 2 (possibly 3) peritoneal samples will be taken by a nurse and will be placed in a specific bag. Each sampling time will be clearly identified on the sample and a traceability form will be completed and sent to the Pharmacology and Toxicology laboratory.
- Conditions
- Peritonitis, Appendicitis, Children, Only, Antibiotic Toxicity
- Being tested
- Dosage of serum and peritoneal of the betalactam used for antibiotic treatment
- Keywords
- Children Peritonitis, Antibiotic diffusion, Pharmacocinetic study
- Medical subject headings
- Peritonitis, Appendicitis
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 betalactam used for antibiotic treatmentOther
All patients will have antibiotherapy according to French recommendation.
Antibiotics recommended are:
cefotaxime 200mg/kg/d / OR amoxicillin/clavulanic acid 25 mg/kg x 3 /d OR piperacilline/tazobactam 100 mg/kg/d
Blood samples will be collected before surgery and after surgery (for all patients).
Peritoneal sample will be collected during surgery (for all patients). Additionnal optionnal blood sample could be collected on Day 5 after surgery. Additionnal optionnal peritoneal samples could be collected on Day 2 and Day 5.
Dosage of serum and peritoneal of the used betalactam will be performed by High Performance Liquid Chromatography Method
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Peritonitis | Other | Patient (from 3 to 17 years-old) treated for appendicular peritonitis. It includes surgical treatment (appendicectomy, peritoneal toilet) and antibiotherapy according to French recommendation. Receives: Other: Dosage of serum and peritoneal of the betalactam used for antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibiotic concentration
Serum betalactams concentrations at different times
Measured: Peritoneal incision, end of surgery, Day+5 after surgery if systemic peritonitis,
antibiotic concentration
Peritonal betalactams concentrations at different times
Measured: During surgery, Day+2 after surgery if drain peritonal, Day+5 after surgery if systemic peritonitis,
Secondary outcomes (15)
Determine elimination rate constant Kel
It is the first order rate constant describing drug elimination from the body.
Measured: Statistical analysis after 2 years of inclusion
Determine estimated initial concentrationf C0
Initial concentration of antibiotic in the body
Measured: Statistical analysis after 2 years of inclusion
Determine Area Under the Curve AUC.
It is the definite integral of a curve that describes the variation of a drug concentration in blood plasma as a function of time.
Measured: Statistical analysis after 2 years of inclusion
Determine Half-life
It is a pharmacokinetic parameter that is defined as the time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50%.
Measured: Statistical analysis after 2 years of inclusion
Determine distribution volume
It is a pharmacokinetic parameter representing an individual drug's propensity to either remain in the plasma or redistribute to other tissue compartments.
Measured: Statistical analysis after 2 years of inclusion
Determine Clearance or betalactams in children
It is a pharmacokinetic measurement of the volume of plasma from which a substance is completely removed per unit time.
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 betalactam
Measured: Statistical analysis after 2 years of inclusion
Proportion of different bacteria
Describe the local bacterial ecology
Measured: Statistical analysis after 2 years of inclusion
Proportion of sensitive and resistant germs to betalactam antibiotics
Describe the local bacterial ecology
Measured: Statistical analysis after 2 years of inclusion
Description of minimal inhibition concentration for bacterias
Describe the local bacterial ecology
Measured: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic under-dosage
Factors statistically associated with antibiotic under dosage defined by serum and peritonal concentrations < 4*MIC using multivariate analysis.
Measured: Statistical analysis after 2 years of inclusion
Factors associated with an antibiotic overdose
Factors statistically associated with antibiotic overdose defined by serum and peritonal concentrations >10*MIC using multivariate analysis.
Measured: Statistical analysis after 2 years of inclusion
Evaluation of duration of hospitalization
Describe the clinical efficacy of antibiotic protocol
Measured: Statistical analysis after 2 years of inclusion
Mean delay for apyrexia
Describe the clinical efficacy of antibiotic protocol
Measured: Statistical analysis after 2 years of inclusion
Clinical complications
Describe the clinical efficacy of antibiotic protocol
Measured: Statistical analysis after 2 years of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start31 Mar 2022 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- PAPE Elise
- Responsible party
- Principal investigator, Nicolas BERTE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308849
- Sponsor's protocol ID
- 2021-A00378-33
- Acronym
- DIFFUPERPED
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis
- ClinicalTrials.gov ID
- NCT05308849
- Acronym / sponsor ID
- DIFFUPERPED / 2021-A00378-33
- Conditions
- Peritonitis, Appendicitis, Children, Only, Antibiotic Toxicity
- Keywords
- Children Peritonitis, Antibiotic diffusion, Pharmacocinetic study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- PAPE Elise
- Study start
- 31 Mar 2022 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Apr 2022 (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.
This is a pilote monocentric prospective study about pediatric peritonitis and antibiotics pharmacokinetic and pharmacodynamic. The investigators will include 41 patients between 3 and 17 years-old during 2 years in the University Hospital of Nancy.
The aim of this study is to determine if the beta-lactam dosages in children recommended by the guidelines for management of intra-abdominal infections permitted the achievement of adequatly serum and peritoneal concentrations in the medical and surgical management of peritonitis.
The investigators will collected serum and peritoneal fluid samples at 3 different times: peritoneal incision, end of surgery, 2 days and 5 days after surgery 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
Pediatric population with localized or generalized appendicular peritonitis with surgical management at the Nancy University Hospital.
Patients are usually taken in emergency at the Pediatric Emergency Department (Children's Hospital, CHRU Nancy). The diagnosis of peritonitis is then made or confirmed by clinical examination and paraclinical tests (biology and imaging).
Written informed consent is obtained from one of the parental authority holders, allowing inclusion in the study. An information document adapted to the child's understanding will also be sent to him/her. The child's non-opposition will be sought if he/she is old enough to understand. The information will be given jointly to the child and to the legal guardians present at the patient's bed at the time of diagnosis of peritonitis. The reflection period will correspond to the interval between this information and the management in the operating room. This may vary depending on the occupation of the operating room.
The diagnosis of appendicular peritonitis is made by the surgeon (routine care). The child is included.
Antibiotic therapy is started IV according to the protocol in force at the CHRU (routine care):
- Cefotaxime (200 mg/kg/d, 4 IV administrations) + Metronidazole (20-30 mg/kg/d, 3 IV administrations)+/-Gentamicin (3-8 mg/kg/d IV)
Specific biological samples and collections are taken for the research:
- A blood sample (1mL) (S0) after injection of the antibiotic and before appendicular section, non-invasive because performed on peripheral venous route.
- A blood sample (1mL) (S1) at the end of the operation, either when the peripheral venous route is placed if possible (non-invasive), otherwise at the periphery (invasive).
- If a drainage of the peritoneal cavity is in place, a non-invasive collection of peritoneal fluid (5 mL) on the drain will be performed (P1) at D2.
- If generalized peritonitis, an additional blood collection (1mL) at D5 (S2) during the biological check-up (routine care). If an abdominal drainage is still in place, a non-invasive collection of peritoneal fluid (5mL) on drain will be performed (P2). At D5, the patients are under appropriate antibiotic therapy.
Specifically for research, betalactam assays are performed on S0, S1, S2, P0, P1 and P2 once all samples have been sent to Pharmacology.
Bacteriological analyses are performed on P0 (routine care), P1 and P2 in real time.
The following specific data will be collected: time of first antibiotic administration, time of sampling (S0, S1 and P0), time of surgery start. Data concerning antibiotic therapy (dosage, frequency of administration) will be collected during the entire hospitalization period as well as the time of the other samples if applicable (S2, P1 and P2).
Clinical and biological data are collected, including the visit at 4-6 weeks after discharge. (In routine care, a visit at 1 month post-op is performed). The investigator looks for AEs or SAEs. At the end of this post-operative visit, the patient is discharged from the study.
The volume of blood collected in the framework of the research is estimated at 3mL, i.e. less than 2.5% of the total blood volume over the inclusion period. The maximum total volume collected is 24 mL (6 mL for research, 18 mL for care, i.e. 3 samples of CBC, blood ionogram and CRP).
Blood and peritoneal samples :
The 3 blood samples as well as the 2 (possibly 3) peritoneal samples will be taken by a nurse and will be placed in a specific bag. Each sampling time will be clearly identified on the sample and a traceability form will be completed and sent to the Pharmacology and Toxicology laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Peritonitis | Other | Other: Dosage of serum and peritoneal of the betalactam used for antibiotic treatmentPatient (from 3 to 17 years-old) treated for appendicular peritonitis. It includes surgical treatment (appendicectomy, peritoneal toilet) and antibiotherapy according to French recommendation. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- diagnosis of intra-abdominal infection : localized or generalized peritonitis secondary to appendix
Key exclusion criteria (3 listed)
- betalactams allergy
- peritonitis with other etiology than appendix
- antibiotic treatment longer than 24h
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 betalactam used for antibiotic treatmentAll patients will have antibiotherapy according to French recommendation. Antibiotics recommended are: cefotaxime 200mg/kg/d / OR amoxicillin/clavulanic acid 25 mg/kg x 3 /d OR piperacilline/tazobactam 100 mg/kg/d Blood samples will be collected before surgery and after surgery (for all patients). Peritoneal sample will be collected during surgery (for all patients). Additionnal optionnal blood sample could be collected on Day 5 after surgery. Additionnal optionnal peritoneal samples could be collected on Day 2 and Day 5. Dosage of serum and peritoneal of the used betalactam will be performed by High Performance Liquid Chromatography Method | Other | Pediatric Peritonitis |
Primary outcome
antibiotic concentration
Time frame: Peritoneal incision, end of surgery, Day+5 after surgery if systemic peritonitis,
Serum betalactams concentrations at different times
antibiotic concentration
Time frame: During surgery, Day+2 after surgery if drain peritonal, Day+5 after surgery if systemic peritonitis,
Peritonal betalactams concentrations at different times
15 secondary outcomes
Determine elimination rate constant Kel
Time frame: Statistical analysis after 2 years of inclusion
Determine estimated initial concentrationf C0
Time frame: Statistical analysis after 2 years of inclusion
Determine Area Under the Curve AUC.
Time frame: Statistical analysis after 2 years of inclusion
Determine Half-life
Time frame: Statistical analysis after 2 years of inclusion
Determine distribution volume
Time frame: Statistical analysis after 2 years of inclusion
Determine Clearance or betalactams in children
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
Proportion of different bacteria
Time frame: Statistical analysis after 2 years of inclusion
Proportion of sensitive and resistant germs to betalactam antibiotics
Time frame: Statistical analysis after 2 years of inclusion
Description of minimal inhibition concentration for bacterias
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 overdose
Time frame: Statistical analysis after 2 years of inclusion
Evaluation of duration of hospitalization
Time frame: Statistical analysis after 2 years of inclusion
Mean delay for apyrexia
Time frame: Statistical analysis after 2 years of inclusion
Clinical complications
Time frame: Statistical analysis after 2 years of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of serum and peritoneal of the betalactam used for antibiotic treatment in people with Peritonitis and Appendicitis, run by Central Hospital, Nancy, 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 1 inclusion and 3 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibiotic concentration (time frame: Peritoneal incision, end of surgery, Day+5 after surgery if systemic peritonitis,). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2022.