Skip to content

Evaluation of BIP Foley catheter in the prevention of catheter associated urinary tract infections in Indian Population (Clinical Phase IV Trial).

Evaluation of BIP Foley catheter in the prevention of catheter-associated urinary tract infections in Indian population (Clinical Phase IV Trial)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/09/006220
Enrollment
1000
Registered
2015-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Prevention of Urinary Tract Infection

Interventions

Intervention1: BIP Foley Catheter: Appropriate size of BIP Foley catheter will be inserted into the vesical cavity of the bladder through the urethra. Catheterisation will be done for at least 48 hour

Sponsors

Bactiguard AB
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients ( >18 years) Patients who are judged of need for indwelling urethral catheter (Foley catheter for at least 48 hours and up to 30 days)

Exclusion criteria

Exclusion criteria: Patient treated with antibiotics for urinary tract infection (UTI) Patient receiving prophylactic antibiotics for catheterization Latex Allergy Patients with surgical interventions in the urinary tract that may interfere with the study results according to the investigator criteria Pregnant or breastfeeding women

Design outcomes

Primary

MeasureTime frame
Incidence of CAUTI according to CDC criteria (in % and No/1000 catheter days)Timepoint: 30 days

Secondary

MeasureTime frame
â?¢ Antibiotic use for treatment of urinary tract infections â?¨ â?¢ Number of spontaneous urinary and blood cultures â?¨ â?¢ Duration of hospitalization â?¨ â?¢ Bacteriuria (â?¥ 105 CFU/ml) â?¨ â?¢ Safety (ADEs)Timepoint: 30 days

Countries

India

Contacts

Public ContactMr Umang Suthar

Ethitrials Clinical Research Solution

bhaumik.mody@ethitrials.com09825060463

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026