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Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis

NCT05308849 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-04-04

No results posted yet for this study

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.

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.

Conditions

  • Peritonitis
  • Appendicitis
  • Children, Only
  • Antibiotic Toxicity

Interventions

OTHER

Dosage of serum and peritoneal of the betalactam used for antibiotic treatment

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

Sponsors & Collaborators

  • PAPE Elise

    collaborator UNKNOWN

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2024-03-31
Completion
2024-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05308849 on ClinicalTrials.gov