Different dosing schedules of ceftazidime‑avibactam plus aztreonam for carbapenem‑resistant Gram‑negative infections

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 trial compares different administration regimens of ceftazidime‑avibactam combined with aztreonam in adults with infections caused by metallo‑β‑lactamase–producing, carbapenem‑resistant Gram‑negative bacteria. Eligible patients have serious infections such as complicated intra‑abdominal infection, hospital‑ or ventilator‑associated pneumonia, complicated urinary tract infection, or bloodstream infection confirmed by genotypic testing. Participants receive the antibiotic combination according to assigned dosing schedules and are followed for clinical, microbiological, and safety outcomes. The study is conducted in a real‑world hospital setting to inform optimal dosing where therapeutic options are limited.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients diagnosed with complicated intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), or bloodstream infection (BSI);
2. Patients with confirmed infections caused by metallo-β-lactamase-producing carbapenem-resistant Gram-negative bacteria (MBL-CR-GNB), as determined by genotypic testing using next-generation sequencing (NGS) or carbapenem resistance gene testing;
3. Patients receiving treatment with ceftazidime-avibactam in combination with aztreonam.

Exclusion Criteria:

1. Patients aged under 18 years;
2. Patients with known hypersensitivity to ceftazidime, avibactam, aztreonam, or any of the excipients; or those with a history of severe hypersensitivity reactions (e.g., anaphylactic shock, severe skin reactions) to any other β-lactam antibacterial agents (such as penicillins, monobactams, or carbapenems);
3. Pregnant or breastfeeding women;
4. Patients unable to comprehend or comply with the study protocol;
5. Any other condition which, in the investigator's discretion, makes the patient unsuitable for participation in the trial.

Where it's running

• Jing Zhou
  Nanjin, Jiangsu, China Recruiting

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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.