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Defining the Clinical Patient Cohort for Infectious Diseases

Case Study:

Defining the clinical patient cohort for a new antibiotic treatment in a conservative and cost-restrictive market


The Client

Our client is a world-leader in the development and supply of antibiotic medicines, with a strong heritage and ambition.  A novel anti-infective brand was deemed too expensive by EU payers vs older standard of care and the disease state where it worked best was not recognised.

European guidelines provided no opportunity for the uptake of the brand. Unlike payers, clinicians (especially KOLs) recognised the disease states addressed by the new brand & the utility of it here.

Therapy Area

Clostridium difficile (CDI) is the leading cause of infectious nosocomial bacterial diarrhoea in industrialized countries. The incidence and severity of C. difficile infection is increasing in most countries and is associated with significant morbidity and mortality. This represents a large clinical burden and potential complications, including pseudomembranous colitis, toxic megacolon, colonic perforation and sepsis.

The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has highlighted recurrence as the most important issue in the management of CDI. Up to 25% of patients suffer a recurrence of infection within 30 days following treatment.  This has patient, clinical, resourcing and health economic implications.


The clinical burden of managing primary cases and recurrences, together with associated management such as cleaning and decontamination, contribute to significant economic costs. US studies estimate the economic burden of CDI to vary between $2,450 and $40,000 per episode. A substantial element of the additional cost relates to the accommodation costs resulting from a prolonged hospital stay.

Overall the cost of CDI is estimated at €3billion per year in the EU and there is concern that this will rise as the population aged >65 years increases.  It is important for appropriate and available treatment to be used as early as possible.

  • Clinical and health economic considerations are important in the EU
  • Antibiotic stewardship varies across the EU
  • Appropriate medicines should be accessible based on clinical need




Our Process

Step 1

A multi-disciplinary group of experts from across the EU were facilitated to pinpoint the challenges to identifying risk factors and the clinical burden and then define a set of statements that described ‘ideal’ practice.

Step 2

A structured online survey was developed and disseminated across other EU-based multi-disciplinary teams. The online survey tested the strength of agreement that existed in relation to all the statements developed.

Step 3

A second facilitated review of the full dataset by the steering group led to the development of a core set of recommendations that reflected the results achieved.  This was informed and substantiated by the consensus achieved for identifying risk factors, iniating appropriate treatment and optimising finite healthcare resources in the EU

Step 4

A manuscript capable of peer-reviewed publication was developed and provided as draft for the steering group to adapt and finalise.  Triducive supported the authors to take ownership of the draft and to submit to the Journal of Hospital Infection for peer review.

Step 5

The publication provided a platform for lobbying activities with the EC to review and improve recognition of clinical need and guide appropriate antibiotic use.

Outcomes & Next Steps

Following submission, the manuscript was accepted for publication by Journal of Hospital Infection and subsequently published. It was also presented at ECCMID.  The client have since worked with Triducive and other partners to develop a range of campaign activities based on this to drive:

  • Awareness of the risk factors via the world’s largest consensus in this therapy area
  • The use of appropriate antibiotic interventions considering clinical and cost-effective demands
  • Educational content and activities
  • Informing future antibiotic stewardship across the EU



responses achieved


expert recommendations

Published in a high impact peer-reviewed journal and presented at medical education events and press

Provided a strong platform for the client to engage with policy makers concerning EU and national antibiotic stewardship


“There is now so much weight of opinion that payers don’t have any reason to say “no”

Brand Director, EU Pharma

“This now provides clear focus in an area that has been confused for a long time”

Microbiologist, Germany

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