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 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. 

 

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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Cam-Cath-001

Strategies for prevention of CAUTI 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 105 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 2023.

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Study Partners

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

 

Norfolk and Norwich University Hospital

Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust

University of Southampton NHS Trust