title: Syndrome Evaluation System (SES) versus Blood Culture (BACTEC) in the Diagnosis and Management of Neonatal Sepsis--A Randomized Controlled Trial.
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.
authors.affiliation: Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India. drvishnubhat@yahoo.com.
authors.forename: B Vishnu
authors.initials: BV
authors.lastname: Bhat
authors.affiliation: Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.
authors.forename: P
authors.initials: P
authors.lastname: Prasad
authors.affiliation: XCyton Diagnostics Pvt Ltd, Peenya, Bangalore, India.
authors.forename: Venkata Banda
authors.initials: VB
authors.lastname: Ravi Kumar
authors.affiliation: Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India.
authors.forename: B N
authors.initials: BN
authors.lastname: Harish
authors.affiliation: XCyton Diagnostics Pvt Ltd, Peenya, Bangalore, India.
authors.forename: K
authors.initials: K
authors.lastname: Krishnakumari
authors.affiliation: XCyton Diagnostics Pvt Ltd, Peenya, Bangalore, India.
authors.forename: Anand
authors.initials: A
authors.lastname: Rekha
authors.affiliation: XCyton Diagnostics Pvt Ltd, Peenya, Bangalore, India.
authors.forename: G
authors.initials: G
authors.lastname: Manjunath
authors.affiliation: Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.
authors.forename: B
authors.initials: B
authors.lastname: Adhisivam
authors.affiliation: Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605006, India.
authors.forename: B
authors.initials: B
authors.lastname: Shruthi
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000071997:Blood Culture / Q000379:methods / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008826:Microbial Sensitivity Tests / Q000379:methods; D058889:Molecular Typing / Q000379:methods / Q000706:statistics & numerical data; D000071074:Neonatal Sepsis / Q000175:diagnosis* / Q000188:drug therapy; D000067716:Point-of-Care Testing / Q000592:standards*; D063189:Symptom Assessment / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents
keywords: Neonatal; Polymerase chain reaction; Sepsis; Syndrome evaluation system (SES)