Molecular Culture for the Diagnosis of Neonatal Sepsis

UnknownOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

July 15, 2023

Primary Completion Date

March 31, 2025

Study Completion Date

August 31, 2025

Conditions
Neonatal Sepsis, Early-OnsetCulture Positive Neonatal SepsisCulture Negative Neonatal SepsisClinical SepsisMicrobial DiseaseNeonatal InfectionMicrobial ColonizationNeonatal Sepsis, Late-Onset
Interventions
DIAGNOSTIC_TEST

Molecular Culture

PCR based technique that amplifies the interspace region in bacterial DNA, that is located between the genes coding for 16S and 23S ribosomal subunits. Primers are used for the majority of known pathogenic phyla, i.e. FAFV, Bacteroidetes, Firmicutes and Proteobacteria. The nucleotide length of the Interspace region is species specific for bacterial single species. Bacteria all have one or multiple alleles for this interspace region. The combination of the amount of alleles, as well as the nucleotide strand length, makes for a specific profile that is distinctive for the species. Available software is able to match this profile to a particular pathogen, enabling confirmation and identification of bacteria in samples within 5 hours in our experimental workflow.

Trial Locations (1)

Unknown

RECRUITING

Maxima Medisch Centrum, Veldhoven

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

InBiome

UNKNOWN

lead

Jip Groen

OTHER

NCT05763680 - Molecular Culture for the Diagnosis of Neonatal Sepsis | Biotech Hunter | Biotech Hunter