NCT07890480 Aztreonam-Avibactam in Immunocompromised Hosts
| NCT ID | NCT07890480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno |
| Condition | Enterobacteriaceae Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 814 participants |
| Start Date | 2026-10-14 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 814 participants in total. It began in 2026-10-14 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the effectiveness and safety of aztreonam-avibactam (ATM-AVI), an antibiotic used to treat infections caused by highly resistant bacteria, in adults with weakened immune systems. The main questions this study aims to answer are: * How well does ATM-AVI work in treating these infections? * How many participants recover, and how many die or develop another infection caused by the same bacteria? * What side effects or medical problems occur during or after treatment? Researchers will also compare participants treated with ATM-AVI with a group of participants previously treated with ceftazidime-avibactam plus aztreonam (CZA-ATM). This comparison will help researchers understand differences in treatment outcomes. The study will include adults with weakened immune systems, such as people with cancer, organ transplants, or those receiving medicines that suppress the immune system. Participants will: * Receive antibiotic treatment chosen by their treating physicians as part of routine medical care. * Have their medical records reviewed to collect information about their infections, treatments, and outcomes. * Be followed for up to 60 days after starting treatment to assess recovery, survival, side effects, and recurrence of infection. * Researchers will not assign treatments or change participants' medical care.
Eligibility Criteria
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.
Contact & Investigator
Fabián Herrera, MD
STUDY CHAIR
CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
Frequently Asked Questions
Who can join the NCT07890480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Enterobacteriaceae Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07890480 currently recruiting?
Yes, NCT07890480 is actively recruiting participants. Contact the research team at maxigabrielcastro@gmail.com for enrollment information.
Where is the NCT07890480 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina.
Who is sponsoring the NCT07890480 clinical trial?
NCT07890480 is sponsored by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno. The principal investigator is Fabián Herrera, MD at CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno". The trial plans to enroll 814 participants.