1982. Multiplex PCR-Based Analysis of Enteric Pathogens in Faecal Samples from Patients with Clostridium difficile Infection in the Randomised, Controlled EXTEND Study Comparing the Efficacy of Extended-Pulsed Fidaxomicin with Vancomycin Therapy
Session: Poster Abstract Session: Clinical Trials
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • 1982_IDWPOSTER (EXTEND BioFire) 14Sep2018.PDF (258.8 kB)
  • Multiplex PCR-Based Analysis of Enteric Pathogens in Faecal Samples from Patients with Clostridium Difficile Infection in the Randomised, Controlled EXTEND Study Comparing the Efficacy of Extended-Pulsed Fidaxomicin with Vancomycin Therapy

    Background: Extended-pulsed fidaxomicin (EPFX) was equivalent to standard vancomycin (SV) for resolving Clostridium difficile infection (CDI) in the EXTEND study. Sustained clinical cure (SCC) at 30 d after end of treatment (EOT) was achieved in 124/177 (70%) patients receiving EPFX vs 106/179 (59%) patients receiving SV (difference 11%; p=0·030). The BioFire platform, a multiplex PCR-based method, was used to detect possible enteric co-pathogens in patients from EXTEND.

    Methods: Patients aged ≥60 y with positive local test for CDI were randomised (1:1) to receive either EPFX (200 mg tablets, twice daily on Days 1–5 and once daily on alternate days on Days 7–25) or SV (125 mg capsules, four times daily on Days 1–10). Stool samples were collected from all patients at screening and analysed using the BioFire FilmArray Gastrointestinal (GI) Panel (Biomérieux). The primary endpoint was the rate of SCC at 30 d after EOT, defined as clinical response (determined by the investigator) and no CDI recurrence. Patients were grouped according to BioFire results, and clinical outcomes were then compared using the Chi-square test and logistic regression analyses.  

    Results: At screening, all patients tested positive for C. difficile toxin A/B by local laboratory test, and 286/332 patients tested positive for C. difficile by BioFire (Figure 1). SCC rates at 30 d after EOT, by baseline presence/absence of enteric co-pathogens, are given in Figure 1, and logistic regression analyses of SCC at 30 d after EOT are given in Table 1.

    Conclusion: SCC-related treatment differences were evident for patients with BioFire-positive C. difficile versus those positive for other enteric pathogens, but were not statistically significant due to low patient numbers in comparator groups.

    Mark Wilcox, MD1,2, Oliver A. Cornely, MD3, Benoit Guery, MD4, Christopher Longshaw, PhD5, Areti Georgopali, MD5, Andreas Karas, MD6, Gbenga Kazeem, PhD7, Jose Alejandro Palacios-Fabrega, PhD7 and Maria J. G. T. Vehreschild, MD8, (1)Healthcare Associated Infections Research Group, Leeds Teaching Hospitals NHS Trust and University of Leeds, Leeds, United Kingdom, (2)Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, United Kingdom, (3)Clinical Trials Centre Cologne (ZKS Köln), Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, University of Cologne, Cologne, Germany, (4)University Hospital and University of Lausanne, Lausanne, Switzerland, (5)Astellas Pharma, Inc., Chertsey, United Kingdom, (6)Astellas Pharma Ltd., Chertsey, United Kingdom, (7)Astellas Pharma Europe Ltd., Chertsey, United Kingdom, (8)University Hospital of Cologne and German Centre for Infection Research, Partner Site Bonn-Cologne, Cologne, Germany

    Disclosures:

    M. Wilcox, Astellas Pharma: Consultant and Grant Investigator , Consulting fee , Research grant , Speaker honorarium and This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. .

    O. A. Cornely, Astellas Pharma: Grant Investigator , Lecture speaker and Scientific Advisor , Research grant , Speaker honorarium and This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. .

    B. Guery, Astellas Pharma: Consultant , Consulting fee and This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. .

    C. Longshaw, Astellas Pharma: CL was a full-time employee of Astellas Pharma, Inc., during the study conduct and is now an employee of Shionogi Europe Ltd.; he also has a patent WO2015169451 A1 pending. and Employee , Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary .

    A. Georgopali, Astellas Pharma: Employee , Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary .

    A. Karas, Astellas Pharma: AK has patents WO2015169451 A1 and EP17167541.6 pending. and Employee , Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary .

    G. Kazeem, Astellas Pharma: Independent Contractor , Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary .

    J. A. Palacios-Fabrega, Astellas Pharma: AP-F has a patent EP17167541.6 pending. and Employee , Medical writing support was provided by Cello Health MedErgy and funded by Astellas. and Salary .

    M. J. G. T. Vehreschild, Astellas Pharma: Consultant and Grant Investigator , Consulting fee , Grant recipient and This study was initiated and sponsored by Astellas. Medical writing support was provided by Cello Health MedErgy and funded by Astellas. .

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