Rationale 

Bacterial biofilms are the recognised cause of recurrent and resistant device-related infections. Research has demonstrated the important role of exposed surface material in both biofilm formation and the subsequent extent of infection. Attempts to mitigate this risk using silver and antimicrobial agents to kill adherent bacteria has had very limited clinical success. Alternatively, coating materials able to inherently prevent bacterial attachment and growth offer significant potential for diminishing the incidence of acquired infections. Camstent has applied this strategy in developing a bacteriaphobic coating for Foley Catheters, responsible for 40% of all nosocomial infections.

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Pilot Study Clinical Evidence

A 150-patient evaluation in four UK hospitals was conducted which demonstrated translation of laboratory findings into clinical care settings. Routine use of commercially available Camstent coated catheters and other catheters was designed, with harvesting of products after patient use for detailed examination. Catheter surfaces were stained to reveal biofilm and mineral density, then measured using confocal microscopy. 

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A consistent decrease in both the mass of biofilm and the type of mineralisation was recorded, with clinically significant accumulations decreased by 95%.  This impact was uniform across the settings and durations of catheterisation, while further supporting claims for enhanced comfort and ease of insertion and withdrawal

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Multi Centre Randomised Clinical Study Cam-Cath-001

Strategies for prevention of Urinary Tract infections (UTI's) are really measures to delay the onset of bacteriuria. Thus, the impact of a bacteriaphobic coating is best demonstrated by its impact on bacterial concentrations in urine. Camstent is conducting a randomised multicentre trial to measure the reduction in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters as compared to uncoated control catheters. Several at-risk populations vulnerable to urinary tract infections are being sampled, with assessment of clinical and economic secondary endpoints. The study is currently enrolling in the UK with results expected in 2024.

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Study Partners

To date, Camstent has partnered in its clinical studies with the following institutions:

 

Pilot Clinical Evidence

Clinical sites:

University College Hospital

James Cook University Hospital

University Hospital Southampton

University of Nottingham Queen’s Medical Centre

University Hospital of Wales

 

Catheter Analyses Sites:

Dept. of Molecular Microbiology at University of Nottingham, UK

Bioscience Technical Facility at the University of York, UK

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ClinicalTrials.gov ID: NCT05719753

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Cam-Cath-001 Clinical Trial

Clinical sites:

Norfolk & Norwich University Hospital NHS Trust

Royal National Orthopaedic Hospital

Stoke Mandeville National Spinal Injury Centre

Royal Berkshire NHS Trust

University of Southampton Hospital NHS Trust

Sciensus Pharma Services Limited

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Participant Identification Centres:

Breckland Alliance Health Living Centre, Norfolk

East coast Community Healthcare, Suffolk

Fakenham Community Centre

Bridgeway Practice

Ashford & St Peters

Shropshire Community Health NHS Trust

 

Catheter Analyses Sites:

Dept. of Molecular Microbiology at University of Nottingham, UK

 

ClinicalTrials.gov ID: NCT04461262