UnknownNot Applicable

Peritoneal Diffusion and Efficacy of Antibiotic Therapy in Pediatric Peritonitis

41 participantsStarted 2022-03-31

Plain-language 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.

Who can participate

Age range

3 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosis of intra-abdominal infection : localized or generalized peritonitis secondary to appendix Exclusion Criteria: * betalactams allergy * peritonitis with other etiology than appendix * antibiotic treatment longer than 24h

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

antibiotic concentration

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

antibiotic concentration

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

Trial details

NCT IDNCT05308849

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Peritonitis trials