Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J01MB) Other quinolones
Other quinolones

Medical condition to be studied

Thrombotic thrombocytopenic purpura
Population studied

Short description of the study population

Patients with a first prescription for either a systemic fluoroquinolone or a systemic broad-spectrum penicillin (or azithromycin). Only the first prescription date for either of the two types of antibiotics was considered. Patients with a concomitant first prescription for both a systemic fluoroquinolone and a systemic broad-spectrum penicillin (or azithromycin), and patients with a history of TTP were excluded.

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)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

10000
Study design details

Main study objective

Is there evidence of an association between systemic fluoroquinolones and acquired TTP? (i.e. is there an increased frequency of acquired TTP following treatment with fluoroquinolones?)

Data analysis plan

The incidence rate of TTP was calculated from the number of patients with TTP during the follow-up period and the total follow-up time in years of follow-up in each of the two treatment groups. The 95% confidence intervals for the incidence rates were calculated.