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Neonatal Sepsis Diagnosis: ; PCR Commercial Technique and Blood Culture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03884894
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 22, 2019
Information provided by (Responsible Party):
Lidia Decembrino, IRCCS Policlinico S. Matteo

Brief Summary:

Although advances in neonatal care have improved survival and reduced complications in preterm infants, sepsis still contributes significantly to mortality and in Neonatal Intensive Care Units (NICUs), in particular for very-low-birth-weight (VLBW, <1500 g) and extremely-low-birth-weight (ELBW, <1000g). Based on the timing of the infection neonatal sepsis has been classified into early-onset sepsis (EOS) and late-onset sepsis (LOS), with differences in the mode of transmission and predominant organisms. EOS is defined as onset in the first 3 days of life generally due to vertical transmission of bacteria from mothers to infants during the intrapartum period. LOS occurs after 3 days of life and it is attributed to pathogens acquired postnatally (horizontal transmission). Considering generally neonatal sepsis in Europe, 90% of the responsible bacteria resulted to be: Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, e Listeria monocytogenes. The diagnosis is difficult because clinical signs, particularly early in the course of disease, are subtle and nonspecific, and laboratory tests and blood culture are not always reliable. Moreover. blood culture (considered the 'gold standard) takes 48-72 hours for result. In fact the cultural method requires the presence of living and vital germs, depends on the volume of the sample - serious problem in neonatal population -, several hours are needed to process the sample, possibly resulting falsely negative in subjects undergoing concomitant antibiotic treatment or a false positive result can be found by contamination. The method based on molecular biology does not require living germs and, therefore, is not characterised by the sensitivity limitations. Such method can result to be extremely effective in patients receiving antibiotic therapy.

In the present study, when an infant has to undergone blood sample for bacteria culture to verify a possible sepsis, a residual blood (200µl) is processed in the same time using a kit based on molecular biology.

This kit is designed to obtain the highest sensitivity and specificity in the determination of most invasive bacterial diseases (meningitis, sepsis, pneumonia, etc.) affecting full-term, preterm infants to determine any presence of bacterial DNA belonging to all serotypes of Klebsiella pneumoniae, Escherichia coli, Streptococcus agalactiae and Listeria monocytogenes.

The target bacteria have been chosen on the basis of the current Italian epidemiological context, so as to include germs causing about 90% of the meningitis/sepsis cases among the neonatal population. The detection system can unmistakably identify the germ against which it is directed and without causing any cross-reaction with other germs or human DNA..

The results obtained with this method have demonstrated a 100% specificity (no false positive result) The sensitivity of this method compared with the cultural method has turned out to be twice as high.

The aim of the present study is to compare the efficacy of the blood culture method and the kit for molecular detection of bacterial DNA (all serotypes of Klebsiella pneumoniae, Escherichia coli, Streptococcus agalactiae and Listeria monocytogenes) considering the relevant epidemiology of our NICU, in order to verify the relative frequency of sepsis (EOS and LOS) caused by the target bacteria on the whole frequency of the bacteria responsible of all the sepsis in our ward.

Condition or disease Intervention/treatment
Sepsis Diagnostic Test: molecular assay Diagnostic Test: Blood culture

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PCR Technique of a Commercial Test and Blood Culture to Early Detect Sepsis in NICU
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
sepsis diagnosis by blood colture/molecular biology
fullterm/ preterm neonates hospitalized in NICU with suspect of sepsis
Diagnostic Test: molecular assay
performed with blood culture simultaneously
Other Name: "EuSepScreen lattanti" diagnostic kit

Diagnostic Test: Blood culture
performed with molecular assay simultaneously

Primary Outcome Measures :
  1. frequency of positive test [ Time Frame: 1 week ]
    to verify the frequency of positive test (neonatal sepsis, EOS or LOS) detected by the molecular assay compare to these of the blood culture

Biospecimen Retention:   Samples With DNA
blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates (full-term or pre-term) requiring to be sampled for suspected sepsis (EOS or LOS)

Infants with: suspected Blood stream infection, hospitalized in the NICU, with SIRS ≥2.

Exclusion Criteria: infants with genetic and/or congenital diseases, parents refusing to sign a written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03884894

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Neonatal Unit, IRCCS Policlinico S. Matteo.
Pavia, PV, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
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Study Director: Mauro Stronati, MD Fondazione IRCCS Policlinico S. Matteo, 27100 Pavia Italy
• Istituto Superiore di Sanità. http// • Shah BA, Neonatal sepsis: an old problem with new insights PadburyJF. Virulence 5:1, 163-171; January 1, 2014; © 2014 • Stoll BJ, Hansen NI, Sánchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, et al.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics 2011; 127:817-26. • Libster R, Edwards KM, Levent F, Edwards MS, Rench MA, Castagnini LA, Cooper T, Sparks RC, Baker CJ, Shah PE. Long-term outcomes of group B streptococcal meningitis. Pediatrics 2012; • Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, et al. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics 2002; 110:285-91; • Levy MM, Fink MP, Marshall JC et al. "2001 SCCM/ESICM/ACCP ATS/SIS International Sepsis Definitions Conference" Critical Care Medicine . 31 n 4 pp: 1250-1256, 2003. • Arnon S. Litmanovitz I. Diagnostic tests in neonatal sepsis. Curr Opinion Infectious Dis 2008; 21: 223-27. • Russell JA. Management of sepsis. N Engl J Med 2006;355:1699-713. • Overturf GD. Defining bacterial meningitis and other infections of the central nervous system. Pediatr Crit Care Med. 2005;6(3 Suppl):S14-8.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lidia Decembrino, MD, IRCCS Policlinico S. Matteo Identifier: NCT03884894    
Other Study ID Numbers: IRCCSPSM/Eusepscreen/2015
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Keywords provided by Lidia Decembrino, IRCCS Policlinico S. Matteo:
neonatal sepsis
Blood culture
molecular assay
Additional relevant MeSH terms:
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Neonatal Sepsis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Infant, Newborn, Diseases