EMIF Use Case 17 - Investigating the relationship in paediatric population between dosing of antibiotics (prescribed, dispensed or administered) and patient’s weight. (EMIF UC17)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01CA04) amoxicillin

  (J01CR02) amoxicillin and beta-lactamase inhibitor

  (J01CE02) phenoxymethylpenicillin

  (J01CE05) pheneticillin

  (J01CF05) flucloxacillin

  (J01DC04) cefaclor

  (J01FA01) erythromycin

  (J01FA10) azithromycin

  (J01FA09) clarithromycin

  (J01CA01) ampicillin

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  3000000

Study design details

• Main study objective:
  The primary objective is to investigate for each DB, the relationship,among the Drug Events, between the antibiotic dosing and the patient’s weight, stratified by:• type of antibiotic (ATC code),• care setting (Hospitalisation/No-Hospitalisation)
• Outcomes:
  The primary objective is to investigate, for each DB, the relationshipamong the Drug Events, between the antibiotic dosing and the patient’s weight, stratified by:• type of antibiotic (ATC code),• care setting (Hospitalisation/No-Hospitalisation), The first secondary objective is to evaluate the frequency distribution of the different types of antibiotics in all DEs, stratified, for each DB, by:• care setting (Hospitalisation/No-Hospitalisation),• calendar year,• age group.The second secondary objective is to investigate, for each DB, the relationshipamong the Drug Events, between the antibiotic dosing and the patient’s BSA
• Data analysis plan:
  Data extraction, transformation, derivation of specific variables will be done locally at each site by data custodians, using purpose-build software called Jerboa Reloaded. The results are transmitted to a central secured environment, namely, a Private Remote Research Environment (PRRE), for further processing and analyses. Since we expect a linear correlation, among the DEs, between the antibiotic dosing (expressed as mg/day) and the patient’s weight (expressed in kilos), this relationship will be investigated scatter-plotting the antibiotic dosing against the patient's weight and computing Pearson's correlation coefficient r.