Study identification

EU PAS number

EUPAS1000000685

Study ID

1000000685

Official title and acronym

DARWIN EU® - Descriptive study of tetanus immunoglobulin use and tetanus-prone wounds in Europe

DARWIN EU® study

Yes

Study countries

Croatia
Germany
Netherlands
Spain
United Kingdom

Study description

Tetanus is a rare but serious neurological condition caused by a neurotoxin from Clostridium tetani, typically introduced through contaminated wounds.
Although vaccine-preventable, tetanus remains a public health concern due to the irreversible nature of the toxin once it enters neurons. Post-exposure prophylaxis, including wound care, tetanus immunoglobulin (TIG), and a booster vaccination, is critical for individuals with tetanus-prone injuries, depending on immunisation status.
In 2022, 53 cases were reported in the European Union (EU), underscoring the importance of timely and appropriate clinical intervention.
This study aims to generate real-world evidence on TIG prescribing patterns and the epidemiology of tetanus-prone wounds across Europe to support regulatory decision-making and inform clinical practice.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Ellen Gerritsen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable