Last reviewed · How we verify
NCT02808000: CDOC
BIP Foley in Prevention of CAUTI at Rehab Station
Phase 4 trial testing BIP Foley (latex) or BIP Foley -silicone in Complications; Catheter, Urinary Infection or Inflammation in 14 participants. Completed in 9 March 2020.
9 March 2020
Quick facts
| Lead sponsor | Bactiguard AB |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 14 |
| Start date | 21 April 2016 |
| Primary completion | 9 March 2020 |
| Estimated completion | 9 March 2020 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- BIP Foley (latex) or BIP Foley -silicone
- Standard catheter
Conditions studied
- Complications; Catheter, Urinary Infection or Inflammation — all drugs for Complications; Catheter, Urinary Infection or Inflammation →
Sponsor
Bactiguard AB
Who can join
18 and older, any sex, with Complications; Catheter, Urinary Infection or Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden. Primary Outcome Measures: • The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs). Secondary Outcome Measures: • to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay. Exploratory Outcome Measures: • assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02808000
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bactiguard AB trials
Trials by the same sponsor.
- NCT03976557 — BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden · NA · terminated
- NCT04242706 — VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02808000 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bactiguard AB
- Last refreshed: 22 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02808000.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing