Clinical Trial

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

Study acronym: PEBBLE
Not Yet Recruiting Phase 4
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-03-16; most recent amendment 2026-04-07.
Trial Details
NCT Number NCT07484633
Lead Sponsor Semmelweis University
Conditions Infection, Sepsis, NICU, PICU, Beta Lactams
Enrollment 110 participants
Start Date 2026-04
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-13