Clinical
Rationale
Bacterial biofilms are a leading cause of recurrent and treatment-resistant device-related infections. Research shows that the exposed surface of a device plays a critical role in biofilm development and the severity of infection.
Traditional approaches—such as silver or antimicrobial agents designed to kill bacteria once attached—have shown limited clinical success. A more effective strategy is to stop bacteria from attaching in the first place.
Camstent has taken this approach by developing a unique Bacteriaphobic® coating for Foley Catheters, which are responsible for around 40% of all hospital-acquired infections.
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.
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.
Pilot Study Paper
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
Biofilm accumulation and mineralization of uncoated (UC) and coated (C) catheters.
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 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 2026.
Study Partners
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 recruiting from the communities
ClinicalTrials.gov ID:
