Aztreonam‑avibactam for MBL-producing CRE infections in hospitalized adults
Aztreonam-Avibactam Real World Study Against Metallo-β-lactamase-Producing Carbapenem-Resistant Enterobacterales
This study will see if aztreonam‑avibactam helps hospitalized adults with complicated intra‑abdominal infections or hospital/ventilator‑associated pneumonia caused by MBL-producing CRE.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Locations | 2 sites (Nanchang, Jiangxi and 1 other locations) |
| Trial ID | NCT07268560 on ClinicalTrials.gov |
What this trial studies
This observational project will collect real‑world treatment and outcome data from Chinese hospitals on adults with confirmed cIAI or HAP/VAP caused by MBL-producing carbapenem‑resistant Enterobacterales who received aztreonam‑avibactam for at least 24 hours. Investigators will record patient characteristics, infection details, microbiology, antibiotic use, hospital length of stay, and clinical outcomes. No experimental interventions are assigned; the study documents care given in routine practice. The aim is to describe how the drug is being used and how patients fare in typical hospital settings in China.
Who should consider this trial
Good fit: Adults (≥18) hospitalized at participating centers with confirmed cIAI or HAP/VAP due to MBL-producing CRE who received on‑label aztreonam‑avibactam for at least 24 hours are ideal candidates.
Not a fit: Patients with infections caused by organisms not expected to respond to aztreonam‑avibactam, those under 18, or those enrolled in interventional trials are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the results could help doctors use aztreonam‑avibactam more effectively, potentially improving recovery and shortening hospital stays for patients with these resistant infections.
How similar studies have performed: Clinical development data and recent approvals in Europe, the U.S., and China indicate activity for aztreonam‑avibactam against MBL-producing organisms, but real‑world outcome data—especially from China—are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Nanchang, Jiangxi and 1 other locations
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Yunsong Yu, PhD
- Email: yvys119@zju.edu.cn
- Phone: 86-13805790432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.