A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients

Phase 4 Not yet recruiting 110 enrolled Semmelweis University

RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to examine the success and safety of administering certain antibiotics (beta-lactams) given in a longer 3-hour infusion to children (0-17 years) who are critically ill and have severe infection. The main question it aims to answer is: Is the longer infusion more effective than the conventional short-term (0.5-hour-long) infusion? Researchers will compare the 3-hour-long infusion group to the 0.5-hour-long infusion group to determine whether the longer infusion can cure the infection earlier and whether it is equally safe. The doses are the same in the two groups. Only the duration differs until the patient receives the antibiotic. Participants will: * be given the required antibiotic drug in a 3-hour-long or in a 0.5 hour-long infusion. * be examined to make sure their blood drug levels are correct. This will require two blood tests. * be treated according to routine care and have examinations and blood tests performed.

Timeline

Start: 2026-04
Primary completion: 2028-04
Completion: 2028-04

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefepime	Small molecule	30 mg/kg	Other
Subject	Cefepime	Small molecule	50 mg/kg	Other
Subject	Ceftriaxone	Other / unclassified	50 mg/kg	Other
Subject	Meropenem	Small molecule	30 mg/kg	Other
Subject	Meropenem	Small molecule	40 mg/kg	Other
Subject	piperacillin/tazobactam	Unknown	90 mg/kg	Other
Subject	piperacillin/tazobactam	Unknown	100 mg/kg	Other

A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients

Summary

Timeline

Publications

Drugs

Indications