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Potential clinical utility of polymerase chain reaction in microbiological testing for sepsis

Lehmann, Lutz Eric MD; Alvarez, Julian MD, PhD; Hunfeld, Klaus-Peter MD, MPH; Goglio, Antonio MD; Kost, Gerald J. MD, PhD; Louie, Richard F. PhD; Raglio, Annibale MD; Regueiro, Benito J. MD, PhD; Wissing, Heimo MD; Stüber, Frank MD

doi: 10.1097/CCM.0b013e3181b033d7
Clinical Investigations

Objectives: To evaluate the potential improvement of antimicrobial treatment by utilizing a new multiplex polymerase chain reaction (PCR) assay that identifies sepsis-relevant microorganisms in blood.

Design: Prospective, observational international multicentered trial.

Setting: University hospitals in Germany (n = 2), Spain (n = 1), and the United States (n = 1), and one Italian tertiary general hospital.

Patients: 436 sepsis patients with 467 episodes of antimicrobial treatment.

Methods: Whole blood for PCR and blood culture (BC) analysis was sampled independently for each episode. The potential impact of reporting microorganisms by PCR on adequacy and timeliness of antimicrobial therapy was analyzed. The number of gainable days on early adequate antimicrobial treatment attributable to PCR findings was assessed.

Measurements and Main Results: Sepsis criteria, days on antimicrobial therapy, antimicrobial substances administered, and microorganisms identified by PCR and BC susceptibility tests.

Results: BC diagnosed 117 clinically relevant microorganisms; PCR identified 154. Ninety-nine episodes were BC positive (BC+); 131 episodes were PCR positive (PCR+). Overall, 127.8 days of clinically inadequate empirical antibiotic treatment in the 99 BC+ episodes were observed. Utilization of PCR-aided diagnostics calculates to a potential reduction of 106.5 clinically inadequate treatment days. The ratio of gainable early adequate treatment days to number of PCR tests done is 22.8 days/100 tests overall (confidence interval 15–31) and 36.4 days/100 tests in the intensive care and surgical ward populations (confidence interval 22–51).

Conclusions: Rapid PCR identification of microorganisms may contribute to a reduction of early inadequate antibiotic treatment in sepsis.

From the Department of Anesthesiology and Intensive Care Medicine (LEL), University Hospital Bonn, Germany; departments of Anesthesiology (JA) and Microbiology (BJR), University Hospital Santiago de Compostela, Spain; departments of Microbiology and Infection Control (K-PH) and Anesthesiology Intensive Care Medicine and Pain Therapy (HW), University Hospital Frankfurt, Germany; Department of Microbiology (AG, AR), Ospedali Riuniti di Bergamo, Italy; Department of Pathology and Laboratory Medicine (GJK, RFL), University of California Davis Medical Center, Sacramento, CA; Department of Anesthesiology and Pain Therapy (LEL, FS), University Hospital Bern “Inselspital,” Bern, Switzerland.

Supported, in part, by Roche Diagnostics, Germany.

Dr. Hunfeld has received speaking fees. Drs. Hunfeld and Wissing have received grant support for lab staff and research. The remaining authors have not disclosed any potential conflicts of interest.

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© 2009 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins