Continuous infusion vs intermittent dosing of ceftazidime/avibactam in critically ill patients

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 is a single-center, randomized, open-label Phase 4 trial at a tertiary hospital in Zagreb, Croatia. It compares continuous infusion of ceftazidime/avibactam to conventional intermittent dosing in critically ill ICU patients with severe infections caused by Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa. Patients are randomized 1:1 and must require ceftazidime/avibactam treatment and have a positive microbiological test for the specified pathogens. The primary goal is to determine which dosing approach more effectively achieves pharmacokinetic/pharmacodynamic targets and clinical outcomes in this high-risk population. Safety and feasibility of continuous infusion in the ICU setting are also monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. General

   1. Age above or equal to 18 years of age.
   2. Able to provide informed consent personally or by his/her next of kin, as requested by the Ethics Committee.
2. Disease-specific

   1. Critically ill patients requiring admission to the intensive care unit (medical or surgical).
   2. Diagnosed with severe infections.
   3. At least one microbiological sample positive for Klebsiella pneumoniae OXA-48 or Pseudomonas aeruginosa.
   4. Requiring a prescription for ceftazidime/avibactam, by clinical judgement

Exclusion Criteria:

1. General

   1. Known or suspected hypersensitivity to ceftazidime/avibactam, excipients, or any other cephalosporin antibacterial agent. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
   2. Withdrawal of informed consent.
   3. Age above 85 years of age.
   4. Female who is pregnant or breast-feeding.
   5. Participation (i.e. signed informed consent) in any other interventional clinical trial of an approved or non-approved antibacterial agent within 30 days before screening.
   6. Any disorder which, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
2. Laboratory values

   1\. Severe neutropenia before or during ceftazidime/avibactam administration.
3. Medical conditions

   1. Death within 48 hours following randomization.
   2. Concomitant acquired immunodeficiency syndrome.
   3. Presence or history of malignant neoplasms or in situ carcinomas.
   4. Duration of ceftazidime/avibactam administration is shorter than 72 hours.

Where it's running

• UHC ZAgreb
  Zagreb, Croatia Recruiting

Study contacts

• Study coordinator: Ivan Šitum, MD
• Email: ivsitum@gmail.com
• Phone: 0915143620

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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.