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IMMUNO-AVI
Study on the Use of Aztreonam-Avibactam for the Treatment of Infections Caused by Metallo-β-Lactamase-Producing Enterobacterales in Immunocompromised Hosts: International Multicenter Prospective Cohort Study
Sponsor study identifier
observational
814
1 country
1
Study Start
October 14, 2026
Actual (reported)Primary Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 14, 2026
Actual (reported)October 16, 2026
Actual (reported)October 22, 2026
Actual (reported)November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
All-Cause Mortality at Day 30
Proportion of participants who die from any cause within 30 days after initiation of aztreonam-avibactam (ATM-AVI) or ceftazidime-avibactam plus aztreonam (CZA-ATM), regardless of the cause of death.
Within 30 days after treatment initiation
Favorable Clinical Response at Day 7
Day 7 after treatment initiation
Clinical Cure at the End of Treatment
At completion of antimicrobial treatment for the index infection
Prospective cohort of immunocompromised adults with microbiologically confirmed monomicrobial infections caused by metallo-β-lactamase-producing Enterobacterales (MBL-E) who receive definitive treatment with aztreonam-avibactam (ATM-AVI) for at least 72 hours. Antibiotic treatment is selected by the treating physician independently of study participation. Clinical and microbiological data will be collected prospectively, and participants will be followed for up to 60 days after treatment initiation to assess clinical effectiveness, safety, mortality, and infection relapse.
Retrospective historical comparison cohort of immunocompromised adults with microbiologically confirmed monomicrobial infections caused by metallo-β-lactamase-producing Enterobacterales (MBL-E) who received definitive treatment with ceftazidime-avibactam plus aztreonam (CZA-ATM) for at least 72 hours. Treatment was prescribed as part of routine clinical care, independently of the study. Clinical, microbiological, treatment, and outcome data will be collected retrospectively from existing medical records using standardized study definitions.
Aztreonam-avibactam (ATM-AVI) administered as definitive antimicrobial treatment for infections caused by metallo-β-lactamase-producing Enterobacterales. Treatment is prescribed as part of routine clinical care, independently of study participation. Dose, administration interval, infusion duration, and treatment duration are determined by the treating physician.
Ceftazidime-avibactam administered in combination with aztreonam as definitive antimicrobial treatment for infections caused by metallo-β-lactamase-producing Enterobacterales. Treatment was prescribed as part of routine clinical care, independently of study participation. Treatment information will be obtained retrospectively from existing medical records.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Ceftazidime-Avibactam Plus Aztreonam
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordThe study population consists of immunocompromised adults with microbiologically confirmed infections caused by metallo-β-lactamase-producing Enterobacterales (MBL-E) receiving care at participating referral hospitals in Europe and the Americas. The prospective cohort will include participants treated with aztreonam-avibactam (ATM-AVI) as part of routine clinical care. The retrospective historical comparison cohort will include participants previously treated with ceftazidime-avibactam plus aztreonam (CZA-ATM). Eligible participants will be identified through routine clinical and microbiological records and included consecutively at participating centers. Treatment decisions are made independently of study participation.
CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
Buenos Aires, City of Buenos Aires, 1431, Argentina
Fabián Herrera, MD
CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
Diego Torres, MD
CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
Maximiliano Gabriel Castro, MD
CEMIC - Centro de Educación Médica e Investigaciones Clínicas "Dr. Norberto Quirno"
First Submitted
October 16, 2026
First Posted
October 22, 2026
Study Start
October 14, 2026
Actual (reported)Primary Completion
November 1, 2028
EstimatedMicrobiological Cure
From treatment initiation through the end of treatment
All-Cause Mortality at Day 7
Within 7 days after treatment initiation
Infection-Related Mortality at Day 7
Within 7 days after treatment initiation
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the results reported in the final publication may be made available to qualified researchers upon reasonable request to the study coordinating team. Shared data may include relevant demographic, clinical, microbiological, treatment, and outcome variables, together with an accompanying data dictionary. Data sharing will be subject to scientific review, applicable ethical approvals, participant confidentiality safeguards, and institutional and national data protection regulations. Direct personal identifiers will not be shared.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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