Peritoneal dialysis patients and their peritoneal dialysis catheter exit site care. MedDRA version: 9.1 Level: LLT Classification code 10008831 Term: Chronic ambulatory peritoneal dialysis
Conditions
Interventions
Trade Name: Bactroban
Product Name: Mupirocin ointment
Product Code: not known
Pharmaceutical Form: Ointment
INN or Proposed INN: MUPIROCIN
CAS Number: 12650690
Pharmaceutical form of the placebo: Cut
Sponsors
Barts and The London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Prevalent PD patients (established on PD for a minimum of 3 months) without evidence of active exit site infection or within 30 days of an episode of peritonitis will be eligible for recruitment. Females of childbearing potential will be advised to use adequate contraception for the duration of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Patients unable to provide informed consent - Known to have an allergy to Prontosan - If patients are enrolled in another interventional study, they will be excluded if inclusion might invalidate the scientific validity of either studies or if there is safety concern.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Daily application of Polhexamethylenbiguinide (PHMB) vs Standard Care (with possible use of Mupirocin ointment) on PD catheter exit sites will lead to 50% reduction of exit site infection related to Gram –ve organisms.;Secondary Objective: Secondary Endpoints: - Non-inferiority of Prontosan treated patients compared with standard care with regards to Gram +ve exit site infection rate - Non-inferiority of Prontosan treated patients compared with standard care with regards to Staph aureus exit site infection rate - Non-inferiority of Prontosan treated patients compared with standard care with regards to Gram +ve peritonitis rate - Non-inferiority of Prontosan treated patients compared with standard care with regards to Staph. Aureus peritonitis rate ;Primary end point(s): Peritonitis is defined as cloudy effluent with >100/ml white cells with >50% of these polymorphonuclear cells. Effluent cultures will be obtained using current standard technique. Catheter infection (exit site and/or tunnel) is defined as erythema, edema, tenderness, or drainage from the exit site. Only one is required to be present for the diagnosis. Cultures will be obtained, but a positive growth is not required. Treatment for infections will be at the discretion of the nephrologists. Infection rates will be calculated as the number of infections divided by the total time at risk and expressed as episodes per patient-year at risk. Catheters removed for refractory exit site infections, refractory peritonitis, and recurrent peritonitis (defined as repetitive episodes with the same organism) will be recorded. | — |
Countries
United Kingdom
Outcome results
None listed