Clinical trial

The Effect of Mupirocin 2% Ointment on the Duration of Stay of Temporary Hemodialysis Catheter Compared to Other Spray Antibiotics

Name
FMASU R85/2023
Description
In dialysis centers, many patients are undergoing hemodialysis simultaneously, which facilitates the spread of microorganisms by direct or indirect contact through the devices, equipment, surface contact, and hands of health profession Over time, catheters are prone to higher rates of infection, thrombosis, and central venous stenosis, it has also been shown that catheters are an independent (of infection) inflammatory stressor and lead to increased morbidity . Catheters are aptly referred to as a bacterial highway, and a biofilm formation around the catheter is often the breeding ground of bacteria and fungi, which can easily spread to the bloodstream Infectious complications are the most serious with regards to patient morbidity and mortality. The incidence could be from 3.8 to5.5 episodes per 1000 days Migration of micro-organism along the external surface of the catheter is probably the most common route of infection through skin and represents 58% .HD catheter has biofilm formation on their surfaces and this serves as a good reservoir for micro-organisms Most patients with end stage renal disease (ESRD) starting hemodialysis through hemodialysis catheter about 9 % in Egypt and most of them require several hemodialysis catheters before maturation of arterio -venous fistula and even after stopping it.
Trial arms
Trial start
2023-04-10
Estimated PCD
2023-05-25
Trial end
2023-05-25
Status
Completed
Phase
Early phase I
Treatment
Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU
The intervention Sprayed 1 to 3 times /day
Arms:
Local antibiotic spray
Other names:
BIVATRACIN
Mupirocin 2% ointment
10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm
Arms:
Mupirocin 2% ointment
Size
150
Primary endpoint
Catheter related infection
45 days
Eligibility criteria
Inclusion Criteria: -Adults patients receiving long-term hemodialysis using temporary right internal jugular hemodialysis catheter Exclusion Criteria: * Age below 16 * Noncompliance patients * Mechanical complications
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-08-22

1 organization

2 products

2 indications

Product
Mupirocin