Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication; Hemodialysis Catheter Infection
• Intervention / Treatment: Drug: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU; Drug: Mupirocin 2% ointment

Detailed Description

Patients receiving hemodialysis have a high risk of infection due to the immunosuppressive effects caused by ESRD, comorbidities, inadequate nutrition and the need for maintenance of vascular access for long periods.

The catheters are rightfully the least preferred modality and, in an ideal setting, no patient should have a catheter as access. Despite the perils associated with dialysis catheters, their use has increased to almost 70% incident dialysis initiation with catheters 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Doaa Elbohy, PhD; Phone Number: 00201224474013; Email: delbohy@gmail.com
• Study Contact Backup: Name: Magdy Elsharkawy, professor; Email: melsharkawy35@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Transplantation Clinic Nasser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Adults patients receiving long-term hemodialysis using temporary right internal jugular hemodialysis catheter

Exclusion Criteria:

• Age below 16
• Noncompliance patients
• Mechanical complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local antibiotic spray; Local antibiotic spray (n=75) The intervention Sprayed 1 to 3 times /day for 45 day Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU Bivatracin Spray	Drug: Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU; The intervention Sprayed 1 to 3 times /day; Other Names: BIVATRACIN
Active Comparator: Mupirocin 2% ointment; (The standard) 10 mm of mupirocin ointment squeezed directly on to their exit sites from a 15 g tube with an outlet diameter of 5 mm mupirocin 2% ointment	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter related infection	Catheter related infection which will manifest by fever rigor and obligatory remove of the catheter.	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average duration of HD catheter	The average duration of HD catheter	45 days

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Chair: Doaa ElBohy, PhD, FUE

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Bacterial Agents; Mupirocin; Neomycin; Bacitracin
• Other Study ID Numbers: FMASU R85/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No