Fast testing for antibiotic resistance in bloodstream infections
Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
This study is testing a faster way to check if antibiotics will work for hospitalized patients with bloodstream infections caused by certain bacteria to see if it helps them get better more quickly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 7 sites (Chaidari, Attiki and 6 other locations) |
| Trial ID | NCT06174649 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a rapid antimicrobial susceptibility testing method called Reveal™ compared to standard of care testing for hospitalized patients with Gram-negative bacteremia. Participants will be randomly assigned to receive either the rapid testing or the standard testing to determine which method leads to better clinical outcomes. The trial aims to address the challenges posed by high resistance rates in Gram-negative bacteria, potentially improving treatment decisions and patient recovery times.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients with positive blood cultures showing Gram-negative bacilli.
Not a fit: Patients with Gram-positive infections or those who have had a recent positive blood culture for Gram-negative bacteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more effective treatment for patients with bloodstream infections caused by Gram-negative bacteria.
How similar studies have performed: Other studies have shown promise in using rapid susceptibility testing methods, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Positive blood culture with Gram stain showing GNB 2. Hospitalized at the time of Gram stain result 3. Enrolled within 16 hours of blood culture positivity Exclusion Criteria: 1. Positive blood culture for GNB within the prior 7 days (if known at the time of Gram stain result) 2. Deceased at the time of Gram stain result 3. Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture 4. Previous enrollment in this study
Where this trial is running
Chaidari, Attiki and 6 other locations
- Attikon University General Hospital — Chaidari, Attiki, Greece (Recruiting)
- Tzaneio General Hospital — Piraeus, Greece (Recruiting)
- Kasturba Medical College, Mangalore — Attavara, Mangalore, India (Recruiting)
- Rambam Health Care Campus — Haifa, Israel (Active_not_recruiting)
- Meir Medical Center — Kfar Saba, Israel (Active_not_recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Active_not_recruiting)
- Complexo Hospitalario Universitario A Coruña (CHUAC) Sergas — La Coruña, Spain (Active_not_recruiting)
Study contacts
- Principal investigator: Ritu Banerjee, MD, PhD — Vanderbilt University Medical Center
- Study coordinator: Ritu Banerjee, MD, PhD
- Email: ritu.banerjee@vumc.org
- Phone: 615-322-3157
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.