Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter

NCT05874219 | Completed Phase 2 DMC

• 1 other identifier: FMASU R85/2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemodialysis Complication; Hemodialysis Catheter Infection

Outcome Measures

Primary Outcomes (1)

• Catheter related infection

  Catheter related infection which will manifest by fever rigor and obligatory remove of the catheter.

  45 days

Secondary Outcomes (1)

• The average duration of HD catheter

  45 days

Study Arms (2)

Local antibiotic spray

EXPERIMENTAL

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

Mupirocin 2% ointment

ACTIVE COMPARATOR

(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

Interventions

Local antibiotic spray Neomycin sulphate 165,000 IU + Bacitracin zinc 12,500 IU DRUG

The intervention Sprayed 1 to 3 times /day

Also known as: BIVATRACIN

Local antibiotic spray

Mupirocin 2% ointment DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age below 16
• Noncompliance patients
• Mechanical complications

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Transplantation Clinic Nasser Institute

Cairo, Egypt

Location

MeSH Terms

Interventions

Bacitracin; Mupirocin; Ointments

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Doaa ElBohy, PhD

  FUE

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 24, 2023
• Study Start: April 10, 2023
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)