title: Impact of the lab-score on antibiotic prescription rate in children with fever without source: a randomized controlled trial.
abstract: BACKGROUND
  The Lab-score, based on the combined determination of procalcitonin, C-reactive protein and urinary dipstick results, has been shown accurate in detecting serious bacterial infections (SBI) in children with fever without source (FWS) on retrospective cohorts. We aimed to prospectively assess the utility of the Lab-score in safely decreasing antibiotic prescriptions in children with FWS and to determine its diagnostic characteristics compared to common SBI biomarkers.
  
  
  METHODS
  Randomized controlled trial in children 7 days to 36 months old with FWS, allocated either to the Lab-score group (Lab-score reported, blinded WBC count) or to the control group (WBC, bands and C-reactive protein determined, blinded procalcitonin and Lab-score), followed up until recovery. Demographic data, antibiotic prescription rate, admission rate and diagnostic properties of the Lab-score were analyzed.
  
  
  RESULTS
  271 children were analyzed. No statistically significant difference concerning antibiotic prescription rate was observed: 41.2% (54 of 131) in the Lab-score group and 42.1% (59 of 140) in the control group (p = 1.000). If recommendations based on the Lab-score had been strictly applied, a hypothetical 30.6% treatment rate would have been encountered, compared to the overall 41.7% observed rate (p = 0.0095). A Lab-score ≥3 showed the following characteristics: sensitivity 85.1% (95% CI: 76.5-93.6%), specificity 87.3% (95% CI: 82.7-91.8%), positive predictive value 68.7% (95% CI: 58.7-78.7%), negative predictive value 94.1% (95% CI: 91.5-97.9%), positive and negative likelihood ratios: 6.68 and 0.17 respectively. Area under the receiver operating characteristic curve was best for the Lab-score (0.911, 95% CI: 0.871-0.950).
  
  
  CONCLUSIONS
  No difference regarding antibiotic treatment rate was observed when using the Lab-score, due to lack of adherence to the related recommendations. However, if strictly followed, a significant 26.5% reduction of antibiotic prescriptions would have been encountered. Medical education needs to be reinforced in order to observe rather than treat low-risk well-appearing children with FWS.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02179398.
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Laurence
authors.initials: L
authors.lastname: Lacroix
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Sergio
authors.initials: S
authors.lastname: Manzano
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Lynda
authors.initials: L
authors.lastname: Vandertuin
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Florence
authors.initials: F
authors.lastname: Hugon
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Annick
authors.initials: A
authors.lastname: Galetto-Lacour
authors.affiliation: Pediatric Emergency Medicine Department, Child and Adolescent Medicine, Geneva University Hospital, Geneva, Switzerland.
authors.forename: Alain
authors.initials: A
authors.lastname: Gervaix
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001424:Bacterial Infections / Q000188:drug therapy* / Q000473:pathology; D015415:Biomarkers / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002116:Calcitonin / Q000097:blood; D015740:Calcitonin Gene-Related Peptide; D005260:Female; D005334:Fever / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007958:Leukocyte Count; D008297:Male; D011498:Protein Precursors / Q000097:blood
chemical_list: D000900:Anti-Bacterial Agents; D015415:Biomarkers; C000606589:CALCA protein, human; D011498:Protein Precursors; D002116:Calcitonin; D002097:C-Reactive Protein; D015740:Calcitonin Gene-Related Peptide