Aztreonam-Avibactam in Immunocompromised Patients with Multidrug-Resistant 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 international observational study collects real-world data on ATM-AVI use in immunocompromised adults with metallo-β-lactamase-producing Enterobacterales infections. It includes a prospective cohort treated with ATM-AVI and a historical comparison group treated with ceftazidime-avibactam plus aztreonam, analyzed with standardized definitions. Outcomes include infection resolution, mortality, recurrent infection, and adverse events. The study aims to inform future treatment decisions for MBL-producing infections in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Adult participants aged 18 years or older with microbiologically confirmed infections caused by metallo-β-lactamase-producing Enterobacterales (MBL-E).
* 2\. Participants must meet at least one of the following immunocompromising conditions: a) solid organ transplant recipients receiving immunosuppressive treatment; b) participants with hematological malignancies or solid tumors who received chemotherapy within the previous 30 days; c) treatment with antilymphocyte or B-cell-depleting agents (e.g., rituximab or alemtuzumab) within the previous 6 months; d) use of biological or targeted therapies associated with immunosuppression (e.g., Bruton tyrosine kinase inhibitors, Chimeric antigen receptor-T cells, immune checkpoint inhibitors with immunosuppressive management, or bispecific antibodies) within the previous 3 months; e) exposure to high-dose corticosteroids, defined as at least 20 mg/day of prednisone or equivalent for at least 14 days within the previous 30 days; f) allogeneic hematopoietic stem cell transplantation (HSCT), with graft-versus-host disease at any time or without graft-versus-host disease during the first year after transplantation; g) autologous HSCT within 6 months after transplantation; h) autoimmune diseases receiving immunosuppressive treatment.
* 3\. Monomicrobial infection caused by MBL-E.
* 4\. Definitive antimicrobial treatment with aztreonam-avibactam (ATM-AVI, prospective cohort) or ceftazidime-avibactam plus aztreonam (CZA-ATM, retrospective cohort) for at least 72 hours.

Exclusion Criteria:

* 1\. Recurrent infections.
* 2\. Infections requiring prolonged antibiotic treatment exceeding 28 days (e.g., osteoarticular infections).
* 3\. Positive microbiological specimens that do not represent a true infection, including: a) asymptomatic bacteriuria; b) respiratory specimens without clinical criteria for pneumonia; c) superficial skin and soft tissue cultures; d) blood cultures obtained through a catheter without confirmation in peripheral blood cultures.
* 4\. Participants receiving palliative care.

Where it's running

• CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
  Buenos Aires, City of Buenos Aires, Argentina Recruiting

Study contacts

• Principal investigator: Maximiliano Gabriel Castro, MD — CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
• Study coordinator: Maximiliano Gabriel Castro, MD
• Email: maxigabrielcastro@gmail.com
• Phone: +5493435144921

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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.