Longer IV infusion of beta-lactams in critically ill children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional study compares extended (3-hour) infusions to standard (0.5-hour) infusions of beta-lactam antibiotics in pediatric patients (0–17 years) with suspected or confirmed infection admitted to NICU/PICU. Participants receive the same total dose, with randomization occurring within 24 hours of eligibility; blood samples are collected to monitor drug levels after steady-state is reached. Safety and efficacy outcomes, along with routine care, will be recorded to determine if longer infusions improve infection control without added risk. Informed consent is obtained from guardians prior to enrollment, and pediatric assent where appropriate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* paediatric patients (0-17 years of age) with suspected or confirmed bacterial infection who are treated in a PICU or NICU and diagnosed with sepsis with a total Phoenix Sepsis Score ≥2 points, and the infection is clinically probable or confirmed by microbiological culture (e.g. from a blood culture, cerebrospinal fluid, urine, trachea, wound, etc.), excluding contamination;
* who are receiving β-lactams including meropenem, piperacillin/tazobactam, cefepime and ceftriaxone;
* who received the same β-lactam therapy within 24 hours prior to inclusion or started new β-lactam therapy due to clinical deterioration;
* written consent of the parent or guardian is obtained.

Exclusion Criteria:

* palliative care patients;
* patients participating in other drug trials;
* patients with impaired renal function if dosing modification is required (estimated Glomerular Filtration Rate \[eGFR\]\<50 mL/min/1.73m2 for meropenem, cefepime, and piperacillin/tazobactam; eGFR\<10 mL/min/1.73m2 for ceftriaxone);
* patients undergoing plasmapheresis (TPE);
* patients undergoing extracorporeal therapy (continuous kidney replacement therapy \[CKRT\] or extracorporeal membrane oxygenation \[ECMO\]);
* β-lactam allergy;
* patients admitted from another institution or department who have been on the same β-lactam treatment for more than 24 hours;
* pregnancy.

Where it's running

• Pediatric Center (Bókay Street Department), Semmelweis University
  Budapest, Hungary Recruiting
• Pediatric Center (Tűzoltó Street Department), Semmelweis University
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Kinga Anna Budai
• Email: budai.kinga@semmelweis.hu
• Phone: +36206632915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.