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Completed

NCT Number: NCT02179398

Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source

Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge. The recently described Lab-score, based on the combined determination of Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in children with FWS, and to prospectively determine the diagnostic characteristics of the Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count, band count and CRP).

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Key information

Conditions

Fever Without Source

Age range

7 day–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children aged 7 days to 3 years old
  • fever without source ≥ 100.4°F (≥ 38.0°C)

Exclusion criteria

  • antibiotics received in the previous 48 hours
  • underlying congenital or acquired immunodeficiency syndrome
  • fever for more than 7 days at presentation

Treatment and study plan

Allocation to the Lab-score group

Biological

Allocation to the control group

Biological

Primary outcomes

  1. Antibiotic Prescription Rate

    Time frame: at PED (Pediatric Emergency Department) presentation

Secondary outcomes

  1. Presence of Serious Bacterial Infection

    Time frame: at 72 hours from PED presentation

  2. Hospitalization Rate

    Time frame: at PED presentation

  3. Sensitivity of a Lab-score ≥ 3

    Time frame: at 72 hours from PED presentation

  4. Specificity of a Lab-score ≥ 3

    Time frame: at 72 hours from PED presentation

  5. Sensitivity of Standard Biological Marker for SBI

    Time frame: at 72 hours from PED presentation

    Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L

  6. Specificity of Standard Biological Marker for SBI

    Time frame: at 72 hours from PED presentation

    Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • BioMérieux

Registry information

Official study title

Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2014
Registry last updated
Oct 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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