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Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis - A Randomized Controlled Trial

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Abstract

Objective

To compare the clinical outcome of a multiplex polymerase chain reaction (PCR) based molecular diagnostic method -- Syndrome Evaluation System (SES) directed treatment strategy vs. standard of care (blood culture) directed treatment strategy for neonatal sepsis.

Methods

This randomized controlled trial (RCT) included 385 neonates with sepsis who were randomized into two groups -- SES and control (BACTEC). Both tests were performed for all the neonates. However, in the SES group, the results of SES test were revealed to the treating clinicians, while in the control group, SES results were withheld. Two ml of blood was drawn from each baby. One aliquot was sent for blood culture, whereas the remaining aliquot was sent for SES. Babies were then administered empirical IV antibiotics and given supportive care. Further antibiotic changes, if required were done in SES and control groups based on their respective reports. The microbiological profile, immediate outcome, duration of hospital stay, number of antibiotics used and readmission within a month in both groups were compared.

Results

SES was better than BACTEC in identifying the causative organism in both the groups (68 % vs. 18 % in SES group and 72 % vs. 18 % in control group). SES had 100 % concordance with blood culture by BACTEC. Detection of bacteria and fungi were four and ten-fold higher respectively with SES when compared to BACTEC culture. Microbiological diagnosis was rapid with SES compared to BACTEC (7 h vs. 72 h). Treatment based on SES resulted in significantly less mortality (3 % vs. 18 %). Readmission rate, duration of hospital stay and change in antibiotics were also significantly less in SES group.

Conclusions

This new molecular based diagnostic system (SES) helps in rapid and accurate diagnosis of neonatal sepsis and reduces mortality and morbidity in affected neonates.

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Acknowledgments

The authors thank Mr. Dipanjan Chakraborty, Head of clinical studies, XCyton Diagnostics Pvt. Ltd for his inputs during the manuscript preparation.

Contributions

BVB, PP, BA and BS were the clinical investigators; BNH did the laboratory analysis; VBRK, KK, AR, and GM conducted the SES test. BVB will act as guarantor for this paper.

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Authors and Affiliations

  1. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India

    B. Vishnu Bhat, P. Prasad, B. Adhisivam & B. Shruthi

  2. XCyton Diagnostics Pvt Ltd, Peenya, Bangalore, India

    Venkata Banda Ravi Kumar, K. Krishnakumari, Anand Rekha & G. Manjunath

  3. Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India

    B. N. Harish

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  1. B. Vishnu Bhat
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Corresponding author

Correspondence to B. Vishnu Bhat.

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Conflict of Interest

The authors (Ravi Kumar BV, Krishnakumari K, Rekha A, Manjunath G) are affiliated to (employed by) XCyton Diagnostics Pvt. Ltd., which holds the patent/know how for Syndrome Evaluation System (SES). Hence, there is a potential conflict of interest.

Source of Funding

Council for Scientific and Industrial Research (CSIR), New Millennium Indian Technological Leadership Initiative.

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Bhat, B.V., Prasad, P., Ravi Kumar, V.B. et al. Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis - A Randomized Controlled Trial. Indian J Pediatr 83, 370–379 (2016). https://doi.org/10.1007/s12098-015-1956-3

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  • DOI: https://doi.org/10.1007/s12098-015-1956-3

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