Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07484633 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this 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
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions: Extended infusion time of one of the following beta-lactams: meropenem or piperacillin/tazobactam or cefepime or ceftriaxone (Drug)… to Extended infusion time of the following beta-lactam: cefepime (Drug), Extended infusion time of the following beta-lactam: ceftriaxone…v3
  2. Interventions: Extended infusion time of beta-lactams (meropenem, piperacillin/tazobactam, cefepime, ceftriaxone) (Drug), Short-term infusion time of… to Extended infusion time of one of the following beta-lactams: meropenem or piperacillin/tazobactam or cefepime or ceftriaxone (Drug)…v2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 13 entries
    • Study description expanded, about 10 words
    • Eligibility criteria expanded, about 4 words
    • Study title shortened, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07484633
Lead Sponsor Semmelweis University
Conditions
(from sponsor)		 Infection, Sepsis, NICU, PICU, Beta Lactams
Related terms Infections, Sepsis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov