Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis

NCT05308849 | Unknown DMC

• 1 other identifier: 2021-A00378-33
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Children Peritonitis; Antibiotic diffusion; Pharmacocinetic study

Outcome Measures

Primary Outcomes (2)

• antibiotic concentration

  Serum betalactams concentrations at different times

  Peritoneal incision, end of surgery, Day+5 after surgery if systemic peritonitis,

• antibiotic concentration

  Peritonal betalactams concentrations at different times

  During surgery, Day+2 after surgery if drain peritonal, Day+5 after surgery if systemic peritonitis,

Secondary Outcomes (15)

• Determine elimination rate constant Kel

  Statistical analysis after 2 years of inclusion

• Determine estimated initial concentrationf C0

  Statistical analysis after 2 years of inclusion

• Determine Area Under the Curve AUC.

  Statistical analysis after 2 years of inclusion

• Determine Half-life

  Statistical analysis after 2 years of inclusion

• Determine distribution volume

  Statistical analysis after 2 years of inclusion

Study Arms (1)

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.

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

Interventions

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

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

Pediatric Peritonitis

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of intra-abdominal infection : localized or generalized peritonitis secondary to appendix

You may not qualify if:

• betalactams allergy
• peritonitis with other etiology than appendix
• antibiotic treatment longer than 24h

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• PAPE Elise: collaborator

MeSH Terms

Conditions

Peritonitis; Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: April 4, 2022
• Study Start: March 31, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 4, 2022

Record last verified: 2022-03