Cellulitis of the leg
Conditions
Interventions
Trade Name: Penicillin VK
Product Name: Penicillin VK
Product Code: 04520/0005
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the place
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ;Secondary Objective: (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. ;Primary end point(s): Time to next episode of cellulitis | — |
Countries
Ireland, United Kingdom
Outcome results
None listed