Evaluation of bioMarkErs to Reduce Antibiotics Use in hospitalizeD nEonates

Not Applicable

Completed

• Conditions: Late-Onset Neonatal Sepsis
• Interventions: Biological: Diagnostic performances of biomarkers combination

• Registration Number: NCT03299751
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).

Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be linked to other neonatal conditions, such as prematurity and birth defects are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity.

Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality.

The primary objective is to identify, on a cohort of 250 patients, the optimal biomarker combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs.

This identification will be carried out, as a secondary objective, with a sub-group of pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity, negative and positive predictive values).

Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-10-03
• Study Start: 2017-11-22
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• patients hospitalized in NICU;

• patients with suggestive signs of LOS including at least one of the following:

  o Fever > 38°C; tachycardia > 160bpm160 bpm; capillary refill time > 3 seconds; grey and/or pale skin complexion; apnea/ bradycardia syndrome,; bloating; rectal bleeding; hypotonia; lethargy; seizures without other obvious cause; increased ventilatory support and/or increased FiO2; cutaneous rash; inflammation at the needle-puncture site of the central venous catheter;

• patients with a standard of care blood sampling, including at least a blood culture;

• consent form signed by at least one parent/ legal representative.

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Exclusion Criteria

• patients treated with antibiotics for a bacteriologically confirmed infection at the moment of/ or 48 hours before blood sampling
• patients who underwent surgery during the 7 days prior to inclusion
• patients vaccinated during the 7 days prior to inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NICU newborns of at least 7 days of life with suggestive signs	Diagnostic performances of biomarkers combination	-

Primary Outcome Measures

Name	Time	Method
LOS diagnosis in NICU newborns of at least 7 days of life with suggestive clinical signs, confirmed by adjudication committee	hour 48	The primary outcome measure will be determined by an independent adjudication committee that will classify the patients into the following categories: infected, not infected or unclassified patients. This committee will be blinded to the biomarkers that will be used to identify a combination with the best negative predictive value. It will be composed of two neonatologists and a pediatrician specialized in the child infectious diseases.; The diagnostic performance of the biomarkers combination will be based on the adjudication committee

Secondary Outcome Measures

Name	Time	Method
LOS diagnosis in NICU preterm neonates, whose weight at birth is less than 1500 grams, of at least 7 days of life, with suggestive clinical signs, confirmed by adjudication committee.	Hour 48	The primary outcome measure will be determined by an independent adjudication committee that will classify the patients into the following categories: infected, not infected or unclassified patients. This committee will be blinded to the biomarkers that will be used to identify a combination with the best negative predictive value. It will be composed of two neonatologists and a pediatrician specialized in the child infectious diseases.; The diagnostic performance of the biomarkers combination will be based on the adjudication committee classification (gold standard).

Trial Locations

Locations (2)

Hospices Civils de Lyon; 🇫🇷 Bron, France

CHU de Nantes; 🇫🇷 Nantes, France