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

Sponsor
Semmelweis University
Study ID
NCT07484633
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Beta Lactams
  • Infection
  • NICU
  • PICU
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
0 Hours - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Extended infusion time of the following beta-lactam: meropenem — DRUG
    Group extended infusion (EI): Duration of infusion is 3 hours (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- meropenem (MPM): 30 mg/kg or 40 mg/kg for meningitis q8h (max. 2 g q8h) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Short-term infusion time of the following beta-lactam: meropenem — DRUG
    Group short-term infusion (SI): Duration of infusion is 0.5 hour (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- meropenem (MPM): 30 mg/kg or 40 mg/kg for meningitis q8h (max. 2 g q8h) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Extended infusion time of the following beta-lactam: piperacillin/tazobactam — DRUG
    Group extended infusion (EI): Duration of infusion is 3 hours (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- piperacillin/tazobactam (TZP): 90 mg/kg piperacillin q6h for non-immunosuppressed patients and 100 mg/kg piperacillin q6h for immunosuppressed patients (max. 4.5 g piperacillin/tazobactam per dose) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Extended infusion time of the following beta-lactam: cefepime — DRUG
    Group extended infusion (EI): Duration of infusion is 3 hours (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- cefepime (CFP): 30-50 mg/kg q8h or q12h (\>1 month: 30 mg/kg every 8-12 hours, 2 months-17 years (bodyweight up to 41 kg): 50 mg/kg every 8-12 hours (max. 2 g per dose; increased dose \[q8h\] used for severe infection and febrile neutropenia) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Extended infusion time of the following beta-lactam: ceftriaxone — DRUG
    Group extended infusion (EI): Duration of infusion is 3 hours (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- ceftriaxone (CTX): 50 mg/kg q12h (max. 4 g per day) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Short-term infusion time of the following beta-lactam: piperacillin/tazobactam — DRUG
    Group short-term infusion (SI): Duration of infusion is 0.5 hour (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- piperacillin/tazobactam (TZP): 90 mg/kg piperacillin q6h for non-immunosuppressed patients and 100 mg/kg piperacillin q6h for immunosuppressed patients (max. 4.5 g piperacillin/tazobactam per dose) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Short-term infusion time of the following beta-lactam: cefepime — DRUG
    Group short-term infusion (SI): Duration of infusion is 0.5 hour (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- cefepime (CFP): 30-50 mg/kg q8h or q12h (\>1 month: 30 mg/kg every 8-12 hours, 2 months-17 years (bodyweight up to 41 kg): 50 mg/kg every 8-12 hours (max. 2 g per dose; increased dose \[q8h\] used for severe infection and febrile neutropenia) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.
  • Short-term infusion time of the following beta-lactam: ceftriaxone — DRUG
    Group short-term infusion (SI): Duration of infusion is 0.5 hour (h) Subset paediatric (P): The doses of beta-lactams are (q…h= every…hours): \- ceftriaxone (CTX): 50 mg/kg q12h (max. 4 g per day) Subset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.

Study Details

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.

Key Dates

First listed
Mar 20, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: pediatric patients, short-term infusion (P, SI) and neonatal patients, short-term infusion (N, SI)
    subset P: 28 days - 17 years subset N: term or pre-term infants \< 28 days of post-natal age, or PMA\* \< 44 weeks \*postmenstrual age
  • Experimental: pediatric patients, extended infusion (P, EI) and neonatal patients, extended infusion (N, EI)
    subset P: 28 days - 17 years subset N: term or pre-term infants \< 28 days of post-natal age, or PMA\* \< 44 weeks \*postmenstrual age

Primary Outcome Measure

Proportion of patients achieving PK/PD index: 100% fT>MIC (Ctrough >MIC) [ Time Frame: two times >48 hours after initiation of antibiotic treatment according to the treatment allocation ]

Central Contacts

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