Complicated Intra-Abdominal Infections, cIAIsAWARENCT07268560
Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
An observational study of Complicated Intra-Abdominal Infections, cIAIs and Hospital-acquired Pneumonia (HAP), run by Sir Run Run Shaw Hospital at 2 sites in China.
Trial summary
Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem. A new combination drug, Aztreonam-Avibactam (we'll call it ATM-AVI), has been developed to fight these tough bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
- What is being tested?
- Aztreonam-Avibactam
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 25 Dec 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. Investigators will start eligibility screening and recruitment from adult patients who have received ≥24 hours of ATM-AVI. The index date is defined as the ATM-AVI initiation date, for which the date of first administration is used. The baseline period spans from 14 days before the index date to the index date, or from the date of admission to the index date, whichever is later. The observations will be both retrospective and prospective. Patients will be followed from ATM-AVI use until death, study withdrawal, or hospital discharge, whichever occurs first. For patients discharged before Day 28, a phone follow-up is necessary for assessment of the 28-day all-cause mortality.
Who may be able to join
- 1. Age 18 years or older 2. Hospitalized with a diagnosis of confirmed cIAI or HAP/VAP 3. Confirmed infection with MBL-producing CRE 4. Received on label use of ATM-AVI treatment for ≥24 hours 5. Informed consent will be obtained or waived.
Who cannot join
- 1. Confirmed or suspected infection caused by Gram-negative species not expected to respond to ATM-AVI 2. Currently enrolled in an interventional clinical tria
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Jingjing Quan, PhD, 86-18268820854, jingjingquan@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Tianxin Xiang, 86+13870090574, txxiangmed@163.com
About this study
Official title: Aztreonam-Avibactam Real World Study Against Metallo-β-lactamase-Producing Carbapenem-Resistant Enterobacterales
Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem. A new combination drug, Aztreonam-Avibactam (we'll call it ATM-AVI), has been developed to fight these tough bacteria.
This new drug was recently approved for use in Europe (April 2024), the United States (February 2025), and China (June 2025). Because it is so new, there is very little information available, especially in China, on how well it works for real patients outside of initial testing.
Read more
This lack of real-world experience means we don't know enough about:
- How effective it is for typical patients in China.
- The types of patients and infections it is used for.
- How it affects a patient's time in the hospital. This study aims to fill these gaps by looking at how ATM-AVI performs in Chinese hospitals, which will help doctors better treat these dangerous infections and improve patient recovery.
What the Study Aims to Find Out
Main Goal:
To see how well ATM-AVI works for adult patients in China with these specific antibiotic-resistant infections.
Other Goals:
To gather more details about:
- How patients are responding to the treatment at different points (e.g., after 5 days, at the end of treatment, and at a follow-up check).
- Whether the bacteria causing the infection are cleared.
- How the treatment affects the patient's hospital stay and use of resources.
- The number of patients who, unfortunately, pass away during or after treatment.
- The characteristics of the patients (like age) and their infections.
- How doctors are using this new drug and if it's used alongside other antibiotics.
How the Study Will Work This is an observational study that will be conducted in about 30 hospitals across China. We plan to include around 100 adult patients who were hospitalized with these tough infections and received the new drug, ATM-AVI, for at least one full day.
The study will run from October 2025 to June 2027. We will look at both past (retrospective) and future (prospective) patients. For past patients, we will review their existing medical records. For future patients, we will ask for their permission (informed consent) before collecting any information.
We will collect information from patient records, such as:
- Basic patient details and the nature of their infection.
- How and when the ATM-AVI drug was used.
- Details about their hospital stay.
- The results of their lab tests. A doctor will assess and record how each patient is doing at key points: 5 days after starting the drug, at the end of the treatment, and at a follow-up check to see if the infection is cured.
- Conditions
- Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
- Being tested
- Aztreonam-Avibactam
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aztreonam-AvibactamDrug
Hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. | The study population consists of hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. Investigators will start eligibility screening and recruitment from adult patients who have received ≥24 hours of ATM-AVI. Receives: Drug: Aztreonam-Avibactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome measure is the proportion of patients who had a clinical response of clinical success, failure, and indeterminate, respectively, which will be assessed at the EOT visit.
The primary descriptive efficacy analysis will be the estimate of the clinical response rate along with nominal 95% CIs using the Clopper-Pearson method.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start25 Dec 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-Abdominal Infections, cIAIsStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268560
- Sponsor's protocol ID
- 98628137
- Acronym
- AWARE
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will include interim report and a final clinical study report. Upon completion of the study and finalization of the study report, the results of this NI study will be submitted for publication and/or posted in a publicly accessible results database. Publications will adhere to the recommendations of the International Committee of Medical Journal Editors (ICMJE).
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aztreonam-Avibactam Real World Study Against Metallo-β-lactamase-Producing Carbapenem-Resistant Enterobacterales
- ClinicalTrials.gov ID
- NCT07268560
- Acronym / sponsor ID
- AWARE / 98628137
- Conditions
- Complicated Intra-Abdominal Infections, cIAIs, Hospital-acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, Zhejiang Provincial People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem. A new combination drug, Aztreonam-Avibactam (we'll call it ATM-AVI), has been developed to fight these tough bacteria.
This new drug was recently approved for use in Europe (April 2024), the United States (February 2025), and China (June 2025). Because it is so new, there is very little information available, especially in China, on how well it works for real patients outside of initial testing.
This lack of real-world experience means we don't know enough about:
- How effective it is for typical patients in China.
- The types of patients and infections it is used for.
- How it affects a patient's time in the hospital. This study aims to fill these gaps by looking at how ATM-AVI performs in Chinese hospitals, which will help doctors better treat these dangerous infections and improve patient recovery.
What the Study Aims to Find Out
Main Goal:
To see how well ATM-AVI works for adult patients in China with these specific antibiotic-resistant infections.
Other Goals:
To gather more details about:
- How patients are responding to the treatment at different points (e.g., after 5 days, at the end of treatment, and at a follow-up check).
- Whether the bacteria causing the infection are cleared.
- How the treatment affects the patient's hospital stay and use of resources.
- The number of patients who, unfortunately, pass away during or after treatment.
- The characteristics of the patients (like age) and their infections.
- How doctors are using this new drug and if it's used alongside other antibiotics.
How the Study Will Work This is an observational study that will be conducted in about 30 hospitals across China. We plan to include around 100 adult patients who were hospitalized with these tough infections and received the new drug, ATM-AVI, for at least one full day.
The study will run from October 2025 to June 2027. We will look at both past (retrospective) and future (prospective) patients. For past patients, we will review their existing medical records. For future patients, we will ask for their permission (informed consent) before collecting any information.
We will collect information from patient records, such as:
- Basic patient details and the nature of their infection.
- How and when the ATM-AVI drug was used.
- Details about their hospital stay.
- The results of their lab tests. A doctor will assess and record how each patient is doing at key points: 5 days after starting the drug, at the end of the treatment, and at a follow-up check to see if the infection is cured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. | – | Drug: Aztreonam-AvibactamThe study population consists of hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. Investigators will start eligibility screening and recruitment from adult patients who have received ≥24 hours of ATM-AVI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. Investigators will start eligibility screening and recruitment from adult patients who have received ≥24 hours of ATM-AVI. The index date is defined as the ATM-AVI initiation date, for which the date of first administration is used. The baseline period spans from 14 days before the index date to the index date, or from the date of admission to the index date, whichever is later. The observations will be both retrospective and prospective. Patients will be followed from ATM-AVI use until death, study withdrawal, or hospital discharge, whichever occurs first. For patients discharged before Day 28, a phone follow-up is necessary for assessment of the 28-day all-cause mortality.
Key inclusion criteria (1 listed)
- 1. Age 18 years or older 2. Hospitalized with a diagnosis of confirmed cIAI or HAP/VAP 3. Confirmed infection with MBL-producing CRE 4. Received on label use of ATM-AVI treatment for ≥24 hours 5. Informed consent will be obtained or waived.
Key exclusion criteria (1 listed)
- 1. Confirmed or suspected infection caused by Gram-negative species not expected to respond to ATM-AVI 2. Currently enrolled in an interventional clinical tria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aztreonam-AvibactamHospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. | Drug | Hospitalized adult patients with MBL-producing CRE infections treated with ATM-AVI. |
Primary outcome
The primary efficacy outcome measure is the proportion of patients who had a clinical response of clinical success, failure, and indeterminate, respectively, which will be assessed at the EOT visit.
Time frame: From enrollment to the end of treatment at 4 weeks
The primary descriptive efficacy analysis will be the estimate of the clinical response rate along with nominal 95% CIs using the Clopper-Pearson method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided. The study will include interim report and a final clinical study report. Upon completion of the study and finalization of the study report, the results of this NI study will be submitted for publication and/or posted in a publicly accessible results database. Publications will adhere to the recommendations of the International Committee of Medical Journal Editors (ICMJE).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Intra-Abdominal Infections, cIAIs and Hospital-acquired Pneumonia (HAP), run by Sir Run Run Shaw Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunsong Yu, PhD (86-13805790432, yvys119@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy outcome measure is the proportion of patients who had a clinical response of clinical success, failure, and indeterminate, respectively, which will be assessed at the EOT visit. (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.