Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000187

EU PAS number

EUPAS1000000187

Study ID

1000000187

Official title and acronym

Acute lower respiratory infections: real-world evidence of antibiotic prescription pattern and costs from a large administrative Italian database

DARWIN EU® study

No

Study countries

Italy

Study description

Through this retrospective observational analysis of the Fondazione ReS (Ricerca e Salute) database, collecting Italian healthcare administrative data, antibacterial for systemic use supplied to subjects aged ≥12 years in 2017 were identified as potentially prescribed to treat an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (39,940; 91%) or an event of community-acquired pneumonia (CAP) (4,059; 9%). The most used antimicrobials were quinolones (37.2% and 39.0% of antibiotics related to AECOPD and CAP, respectively), third-generation cephalosporins (25.5%; 27.5%), penicillins (15.4%; 14.9%), and macrolides (14.4%; 11.3%). Costs of each patient supplied with the antibacterial to treat AECOPD/CAP were assessed within 30 days after the antibacterial supply. Overall, the integrated cost of the association AECOPD/CAP-antibacterial was higher if the patient was hospitalized due to AECOPD/CAP before the antibacterial supply (€5,006/€4,966, respectively). The integrated expenditure of a patient treated for AECOPD not requiring hospitalization was €647. Findings showed a substantial antimicrobial use in Italy for the 2 acute lower respiratory tract infections, highlightening the need of improving the current prescribing practice or developing new molecules. This study also provided healthcare integrated costs of these associations as a proxy of the complexity and frailty of patients experiencing an AECOPD/CAP event.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Letizia Dondi

Primary lead investigator
ORCID number:
0009-0001-3168-6856
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This research was partially supported by an unconditional grant from Zambon Italy. Zambon Italy was not involved in data collection, analysis, and interpretation, in writing the report, nor in deciding to submit the article for publication.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable