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Life sciences · Phase 4 Trial
ClinicalTrials.gov · November 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07484633). This is a study registration, not published results. Lead sponsor: Semmelweis University. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 110 participants (ESTIMATED). Conditions: Infection, Sepsis, NICU, PICU, Beta Lactams. Interventions: DRUG: Extended infusion time of the following beta-lactam: meropenem; DRUG: Short-term infusion time of the following beta-lactam: meropenem; DRUG: Extended infusion time of the following beta-lactam: piperacillin/tazobactam; DRUG: Extended infusion time of the following beta-lactam: cefepime; DRUG: Extended infusion time of the following beta-lactam: ceftriaxone; DRUG: Short-term infusion time of the following beta-lactam: piperacillin/tazobactam; DRUG: Short-term infusion time of the following beta-lactam: cefepime; DRUG: Short-term infusion time of the following beta-lactam: ceftriaxone. Primary outcome measures: Proportion of patients achieving PK/PD index: 100% fT>MIC (Ctrough >MIC) , two times >48 hours after initiation of antibiotic treatment according to the treatment allocation. Brief 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.