E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
PATCH I: To determine whether 12 months of prophylaxis with penicillin VK is effective in reducing repeat episodes of cellulitis in patients with recurrent cellulitis of the leg. PATCH II: To determine whether 6 months of prophylaxis with penicillin VK is effective in reducing repeat episodes of cellulitis in patients who have had cellulitis of the leg (first or multiple episodes).
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E.2.2 | Secondary objectives of the trial |
(1) To determine whether protective benefits are observed only whilst treatment is maintained, or if benefits can continue in the longer term. (2) To comment on the optimum duration of prophylaxis by comparing the results of the two studies. (3) To determine which baseline factors best predict treatment success. (4) To assess whether the routine use of medium-term prophylaxis results in cost savings for the NHS. (5) To evaluate whether there are any specific safety issues with regard to using Penicillin VK in this setting. (6) To assess the impact of cellulitis on health-related quality of life.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
PATCH I (1) Diagnosis of cellulitis of either leg (index episode) (2) History of at least one previous episode of cellulitis of either leg within the three years prior to the index episode. PATCH II (1) Diagnosis of cellulitis of either leg (index episode) |
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E.4 | Principal exclusion criteria |
Any doubt about the certainty of the diagnosis of either the index episode or the previous episode (if applicable), will be grounds for exclusion. Additionally, patients with any of the following will be excluded: (1) Already taking prophylactic antibiotics for the prevention of cellulitis prior to index episode. (2) A time lapse of longer than 26 weeks since the start of treatment for the index episode to the date of potential randomisation into the trial. (3) Known allergy to penicillin. Prospective participants will be questioned as to the nature of their previous allergic reaction in order to assess whether it was a true allergic response or simply an intolerance to the antibiotic. This questioning will address the following points: i) whether the patient experienced a rash; ii) when the reaction occurred in relation to administration of the drug; iii) which type of penicillin they had. Should the clinician believe the reaction to have been intolerance rather than an allergic reaction, the clinician will talk the issue through with the patient. The final decision as to whether to take part in the trial will obviously rest with the patient. (4) Preceding leg ulceration, surgery or penetrating trauma, as these cases are more likely to be caused by staphylococcal infection. (NB: this does not exclude patients with toeweb maceration/tinea pedis or other minor/blunt wounds). (5) Treating physician or principal investigator unwilling to randomise patient. This includes, but is not limited to: i) the treating physician recommends that the patient requires prophylactic antibiotics (ie not willing/able to accept randomisation); ii) concomitant medication that would mean that long-term penicillin VK is inappropriate; iii) diagnostic uncertainty; iv) confounding concurrent disease (eg DVT). (6) Aged less than 16 years. (7) Unable to give informed consent. (8) Already taking part in a research study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to next episode of cellulitis |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 30 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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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The end of the trial will be defined as the date of the last treatment dose for the last patient. Any of the well documented side-effects of penicillin VK should appear during the treatment phase. Therefore, since the purpose of this study is to establish the efficacy of penicillin VK in reducing the chances of a repeat attack of cellulitis, it is not appropriate to continue with pharmaco-vigilance during the follow-up phase. |
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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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |