| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
Prevention of central venous catheter-related infections in haemodialysis patients.
This trial will evaluate the effectiveness of 2% chlorhexidine gluconate in 70%isopropyl alcohol as a skin, exit site and catheter hub cleansing agent in the reduction of CVC-related infections in haemodialysis patients, in comparison to the other forms of chlorhexidine gluconate that are in routine use in dialysis centres in Ireland.
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol versus 0.05% aqueous chlorhexidine gluconate or 0.5% chlorhexidine gluconate in 70% isopropyl alcohol, on the reduction of CVC-related infections (catheter-associated bloodstream infections, catheter-related bloodstream infection and local access infection) in haemodialysis patients. |
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| E.2.2 | Secondary objectives of the trial |
To compare the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol to 0.05% aqueous chlorhexidine gluconate or 0.5% chlorhexidine gluconate in 70% isopropyl alcohol on:
•Time to development of first CVC-related infection
•Patient mortality secondary to infection
•CVC-related infection rates according to causative organism
•Time to infection associated catheter removal
•Episodes of hospitalisation
•Incidence of adverse reactions
•Economic cost
•Incidence and prevalence of AVF, AVG and CVC use in haemodialysis population
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Patients over the age of 18 who require haemodialysis for end stage renal disease (ESRD)
•Patients on long term haemodialysis using a permanent tunnelled cuffed CVC
•Patients whose permanent tunnelled cuffed CVC has been inserted at least four weeks prior to entry into the study (to avoid recruiting patients who may develop infection secondary to insertion technique)
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| E.4 | Principal exclusion criteria |
•Patients whose CVC is used for purposes other than access for haemodialysis
•Patients with a known allergy to any component of the interventions
•Patients whose CVC material is not compatible with interventions
•Patients who are using central venous catheters or dressings which are not standard practice for the unit
•Patients who are unable to give informed consent
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| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary end point with be bloodstream infection secondary to central venous catheter. The CDC/NHSN Laboratory Confirmed Primary Bloodstream Infection definitions (2008) and the Infectious Disease Society of America’s Clinical Definitions of Catheter-related Infections (2009) will be used to diagnose catheter-associated bloodstream infection and catheter-related bloodstream infection (CRBSI). To enable comparisons with International literature the CDC/NHSN (2009) Dialysis Events specific outcomes measures will also be included. These outcomes are local access infection, access-associated bacteraemia and vascular access infection.
The CDC/NHSN Dialysis Events specific outcomes measures are:
•Local access infection: Pus, redness or swelling of the vascular access site and access-associated bacteraemia was not present and patient was hospitalised or had initiation of an IV antimicrobial agent.
•Access-associated bacteraemia: Positive blood culture with source identified as the vascular access site or unknown.
•Vascular access infection: Either local infection or access-associated bacteraemia
Bloodstream infections can be classified as either catheter-associated or catheter-related. According to the CDC/NHSN (2008) laboratory confirmed primary bloodstream infections are recorded as catheter-associated bloodstream infections if a CVC was in place at the time of or within 48 hours before the development of the BSI. Laboratory Confirmed Bloodstream Infection must meet at least one of the following criteria
Criteria 1:
Patient has a recognized pathogen cultured from one or more blood cultures
and
Organism cultured from blood is not related to an infection at another site.
Criteria 2:
Patient has at least one of the following signs or symptoms: fever (>38oC), chills, or hypotension
and
Signs and symptoms and positive laboratory results are not related to an infection at another site
and
Common skin contaminant (i.e., diphtheroids [Corynebacterium spp], Bacillus [not B anthracis] spp, Propionibacterium spp, coagulase negative staphylococci [including S epidermidis], viridans group streptococci, Aerococcus spp, Micrococcus spp) is cultured from two or more blood cultures drawn on separate occasions.
Notes
In criterion 1:
•The phrase ‘1 or more blood cultures’ means that at least 1 bottle from blood drawn is reported by the laboratory as having grown organisms (i.e., is a positive blood culture)
•The term ‘recognized pathogen’ does not include organisms considered common skin contaminants (see criteria 2 and 3 for a list of common skin contaminants).
•A few of the recognized pathogens are Staphylococcus. aureus, Enterococcus spp, Escherichia. coli, Pseudomonas spp, Klebsiella spp, Candida spp, and others
In criteria 2:
•The phrase ‘2 or more blood cultures drawn on separate occasions’ means (1) that blood from at least 2 blood draws were collected within 2 days of each other (e.g., blood draws on Monday and Tuesday or Monday and Wednesday would be acceptable for blood cultures drawn on separate occasions, but blood draws on Monday and Thursday would be too far apart in time to meet this criterion) and (2) that at least 1 bottle from each blood draw is reported by the laboratory as having grown the same common skin contaminant organism (i.e., is a positive blood culture)
•A blood culture may consist of a single bottle for a paediatric blood draw because of volume constraints. Therefore, to meet this part of the criterion, each bottle from 2 or more draws would have to be culture positive for the same skin contaminant
The diagnosis of CRBSI is problematic in that clinical findings alone are unreliable and lack specificity and sensitivity. A definitive diagnosis of CRBSI can be made when other sources of infection have been excluded and the culture of the catheter tip provides the microbiological evidence implicating the catheter as a source of the BSI.
The rate of CVC-related infection will be expressed as the number of catheter-related infections per 100 patient months (CDC/NHSN 2009).
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Recruitment will take place over an eight month period. Each patient will be followed up for 12 months. End of trial will be when data capture is completed 20 months from the recruitment of the first patient.
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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