Molecular Culture for the Diagnosis of Pediatric Sepsis

NCT06018792 | Recruiting

• 1 other identifier: NL84592.018.23
• Study Type: observational
• Target: 1,835
• Locations: 1 country
• Sites: 2

Brief Summary

Babies and children have an increased risk of getting an infection with a bacteria in the bloodstream (sepsis). It is often difficult for the doctor to determine whether a child has an infection of the bloodstream, because the symptoms are often unclear and can also occur in children who are not sick. To determine whether there is an infection, a little blood is currently taken for a blood test (the blood culture) to investigate whether there is a bacteria in the blood. However, it often takes at least 36 hours before the results of this blood culture are available. That is why antibiotics are usually started immediately to treat the possible infection. However, it often turns out that the blood culture is negative after 36 hours, which means that no bacteria have been found in the blood. Usually the antibiotics are then stopped because it turns out that there was no infection at all. There is currently no good test that can predict whether (newborn) children have an infection or not. That is why too many children are currently wrongly receiving antibiotics. These antibiotics can damage the healthy bacteria in the intestines. There are many billions of 'beneficial bacteria' in the intestine. These play an important role in the digestion of food and protect against external infections. Antibiotics aim to kill bacteria that cause inflammation or infection. Unfortunately, antibiotics also kill some of these beneficial bacteria. In addition, unnecessary use of antibiotics contributes to antibiotic resistance. The aim of this research is to investigate whether Molecular Culture, a PCR based test that can identify bacterial pathogens in bodily fluids within 4 hours, has greater accuracy than traditional culturing techniques for bacteria in blood. If proven, this could lead to faster identification or exclusion of sepsis in children.

Conditions

Sepsis; Sepsis Bacterial; Sepsis, Neonatal; Infection, Bacterial; Antibiotic Side Effect; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of MC for the result of the conventional blood culture in newborns and children suspected of sepsis

  We will analyse test characteristics and provide test sensitivity, specificity and positive and negative predictive values. Based on previous studies, we hypothesize that MC will be positive in all samples that are positive by conventional blood culture. We hypothesize that MC will yield more false positives or contaminants than conventional culture.

  Up to 2 weeks after sampling of blood

Secondary Outcomes (2)

• diagnostic accuracy of MC for (clinical) sepsis and compare this with the diagnostic accuracy of the conventional blood culture for (clinical) sepsis.

  Up to 2 weeks after sampling of blood

• diagnostic accuracy of MC on blood samples drawn after initiation of empirical antibiotics, for the result of the conventional blood culture in samples, drawn at initial sepsis workup

  Up to 2 weeks after sampling of blood

Study Arms (4)

Pediatric sepsis

Study participants aged 3 months - 18 years who undergo collection of blood for conventional blood culture

Diagnostic Test: Molecular Culture

Late onset sepsis

Study participants aged up to 3 months who undergo culturing of blood for conventional blood culture Preterm infants aged \<32 weeks gestational age as a subgroup

Diagnostic Test: Molecular Culture

Early onset sepsis

Study participants aged up to 3 days who undergo culturing of blood for conventional blood culture

Diagnostic Test: Molecular Culture

Post antibiotic initiation cohort

participants for whom venipuncture is performed for follow up of inflammatory parameters \<36h after antibiotic initiation and blood draw for conventional culture or for whom a repeat intravenous catheterization is performed due to failing of a previous one \<36h after antibiotic initiation and blood draw for conventional culture

Diagnostic Test: Molecular Culture

Interventions

Molecular Culture DIAGNOSTIC_TEST

PCR based bacterial profiling technique, that creates a differentiating microbial signature based on amplification of the interspace region in bacterial ribosomal RNA. Results on gel capillary electrophoresis are analyzed with software to recognize these signatures.

Also known as: IS Pro

Early onset sepsis; Late onset sepsis; Pediatric sepsis; Post antibiotic initiation cohort

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All minors aged \<18 years

You may qualify if:

• Undergoing collection of blood for a conventional blood culture as part of standard care OR
• Having undergone sepsis evaluation collection of blood for a conventional blood culture as part of standard care in the past 72 hours

You may not qualify if:

• Auto inflammatory disease
• Hemophagocytic syndrome
• SIRS (Systemic Inflammatory Response Syndrome following a severe viral infection

Sponsors & Collaborators

• Jip Groen: lead
• InBiome: collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Spaarne Gasthuis

Haarlem, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Unprocessed blood

MeSH Terms

Conditions

Sepsis; Neonatal Sepsis; Bacterial Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bacterial Infections and Mycoses; Disease Attributes

Study Officials

• Tim de Meij, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tim de Meij, MD, PhD

CONTACT

+3120 566 9111; t.demeij@amsterdamumc.nl

Jip Groen, MD

CONTACT

+3120 566 9111; j.groen5@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor, PhD candidate

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 31, 2023
• Study Start: March 10, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)