OpGen Announces Data from Prospective Randomized Controlled Multicenter Clinical Study Using the Unyvero HPN Panel for Hospitalized Patients with Suspicion of Pneumonia
- Unyvero reduced the use of inappropriate antibiotic therapy by 45.1%
- Unyvero shortened inappropriate antibiotic therapy by 39 hours, and reduced overall antibiotic therapy duration by 22.54%
- 3 x higher probability of avoiding inappropriate antibiotic therapy in the patient group diagnosed by Unyvero
- Unyvero results combined with antibiotic stewardship are efficient and safe in decreasing time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative bacteria
The webinar titled “Multiplex Bacterial PCR in Bronchoalveolar Lavage (BAL) - Does It Impact Inappropriate Antibiotic Use?” described the study which assessed the clinical utility and impact of the Unyvero panel in hospitalized adult patients with suspicion of pneumonia and a clinical indication for bronchoscopy and at risk for infection with Gram-negative bacteria. The primary study endpoint was duration of inappropriate antibiotic therapy.
740 patients were screened, of which 208 eligible patients underwent randomization; 100 patients were randomized to the intervention group (also referred to as the PCR group; BAL was analyzed by conventional culture as well as determination of Gram-negative bacteria using the Unyvero HPN panel), and 108 patients were randomized to the control group (BAL was analyzed solely by conventional culture). Within 4 hours after bronchoscopy Unyvero results were available and shared with the attending physician treating the patients in the intervention group.
Pulmonary physician Prof.
- Inappropriate antibiotic treatment was significantly shorter in the PCR group – Unyvero decreased the average duration of inappropriate antibiotic therapy from 86 hours in the control group to 47 hours in the PCR intervention group; the low P-value p<0.0001 suggests the robustness and high statistical significance.
- Inappropriate antibiotic therapy was reduced by 45.1% in the PCR group.
- Duration of antibiotic therapy altogether was reduced by 22.5% in the PCR group.
- Probability of avoiding inappropriate antibiotic therapy was 3 times higher in the patient group that was diagnosed by Unyvero.
- Clinical stability, including reaching clinical stability and/or being discharged, time to clinical stability or discharge, length of hospital stay, ICU admission, and 30-day mortality were assessed to determine if decreasing the amount of antibiotics or reduction in use of broad-spectrum antibiotics in the intervention group worsened patient outcomes, and the findings suggested that there was no significant difference in the two randomized groups.
- In terms of diagnostic performance, Gram-negative rods in BAL were detected more commonly by Unyvero PCR than conventional culture – 45 bacteria in 39 patients vs. 32 bacteria in 33 patients, respectively.
The study concluded that “The results of Unyvero combined with antibiotic stewardship is efficient and safe in decreasing time on inappropriate antibiotic therapy in hospitalized patients with pneumonia at risk for Gram-negative rods.”
A recording of this webinar will be available at OpGen.com.
About Unyvero Lower Respiratory Tract Panels
The Unyvero Hospitalized Pneumonia (HPN) panel detects 21 clinically relevant pathogens and 17 antibiotic resistance markers in less than five hours directly from native specimens with only around two minutes of hands-on time, compared to routine bacterial cultures that can take up to several days for confirmatory pathogen identification and antimicrobial susceptibility testing results. In the
For more information, please visit www.opgen.com.
This press release includes statements regarding the clinical utility of the Unyvero Hospitalized Pneumonia panel based on the results of studies conducted by independent infectious disease professionals. These statements and other statements regarding OpGen’s future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the fact that we may not effectively use proceeds from our financings, the realization of expected benefits of our business combination transaction with
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Source: OpGen, Inc.