Study identification

PURI

https://redirect.ema.europa.eu/resource/42642

EU PAS number

EUPAS42641

Study ID

42642

Official title and acronym

Rapid Data Analysis – Systemic fluoroquinolones and thrombotic thrombocytopenic purpura (TTP)

DARWIN EU® study

No

Study countries

Germany
United Kingdom

Study description

Fluoroquinolone antibiotics (of which ciprofloxacin is an example) are widely used for the treatment of certain types of microbial infection. Recently, their use has been reported as being associated with the onset of Thrombotic Thrombocytopenic Purpura (TTP), a rare but potentially fatal disease that causes blood clots to form in small blood vessels throughout the body. This issue is being evaluated by the European Union’s Pharmacovigilance Risk Assessment Committee (PRAC), a regulatory body responsible for assessing and monitoring the safety of human medicines. This study simply describes how often TTP occurs after patients are prescribed fluoroquinolones. To allow contextualisation of the results, the same analysis has been done in two other groups of patients prescribed other antibiotic medicines. The first group are patients prescribed broad spectrum penicillins. The second group are patients who have been prescribed azithromycin. The results of this study will be used by the PRAC in its decision-making process by helping to decide if regulatory action needs to be taken to protect patients taking fluoroquinolones.

Study status

Finalised
Research institution and networks

Institutions

Contact details

EMA EMA

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Analysis-Plan_fluoroquinolones_TTP

English (497.61 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable