E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Peritoneal dialysis patients and their peritoneal dialysis catheter exit site care. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008831 |
E.1.2 | Term | Chronic ambulatory peritoneal dialysis |
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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 |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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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 | No |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |