Randomised controlled trials to investigate whether prophylactic antiobiotics can prevent further eisodes of cellulitis (erysipelas) of the leg (PATCH I & PATCH II). - PATCH I & PATCH II

• Conditions: Cellulitis of the leg

• Registration Number: EUCTR2006-000381-36-IE
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

PATCH I:

(1) Diagnosis of cellulitis of eith leg (index episode).

(2) History of at least one previous episode od 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

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 12 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 deem that the reaction was intolerance rather than an allergic reaction, the clinician will discuss this issue further with the patient. The final decision as to whether to take part in the trial will 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 and/or patient feels that prophylactic antibiotics are not in the patient’s best interests and therefore entry to this study would be inappropriate.
ii) the treating physician and/or patient feels it would not be ethical or appropriate for the patient to receive placebo and so they are not willing/able to accept randomisation
ii) concomitant medication that would mean that long-term penicillin VK is inappropriate;
iii) diagnostic uncertainty;
iv) gastrointestinal disease causing persistent diarrhoea or vomiting severe enough to affect the absorption of the phenoxymethylpenicillin.
v) allergic diathesis or severe bronchial asthma severe enough to preclude the use of phenoxymethylpenicillin.
vi) confounding concurrent disease (eg DVT).

(6) No access to a telephone.

(7) Aged less than 16 years.

(8) Unable to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified