Evaluating the effectiveness of CAZ/AVI and FOS for treating CRE infections
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to Carbapenem-resistant Enterobacterales (CRE)
This study is testing whether a combination of two antibiotics, ceftazidime/avibactam and fosfomycin, can help adults with tough infections caused by drug-resistant bacteria feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT06717594 on ClinicalTrials.gov |
What this trial studies
This multicenter international observational study focuses on adult patients with infections caused by carbapenem-resistant Enterobacterales (CRE). It aims to assess the efficacy of ceftazidime/avibactam (CAZ/AVI) alone or in combination with fosfomycin (FOS) in achieving optimal drug exposure and patient response. The study will analyze pharmacokinetics and pharmacodynamics to determine the best treatment approaches for these challenging infections. By documenting patient outcomes, the study seeks to establish a standardized approach to managing CRE infections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been treated for at least 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically confirmed CRE infection.
Not a fit: Patients with polymicrobial infections or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from severe infections due to antibiotic-resistant bacteria.
How similar studies have performed: While the approach of combining CAZ/AVI with FOS has shown promise in vitro, this specific observational study is novel and aims to provide real-world evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signature of the informed consent * Age ≥ 18 years * Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection Exclusion Criteria: * Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs
Where this trial is running
Bologna, Bologna and 1 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- Instituto de Biomedicina de Sevilla (IBiS), Hospital Virgen Macarena/CSIC/Universidad de Sevilla — Seville, Seville, Spain (Recruiting)
Study contacts
- Principal investigator: Maddalena Giannella, MD PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Maddalena Giannella, MD PhD
- Email: maddalena.giannella@unibo.it
- Phone: +390512143199
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.