Prophylactic Antibiotics for the Treatment of Cellulitis at Home I

Completed

• Conditions: Recurrent cellulitis of the leg; Cellulitis; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN34716921
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Aged over 16 years - no upper age limit, either sex
2. At least one previous episode of cellulitis of either leg within the three years prior to the current acute index episode of cellulitis.

Exclusion Criteria

Added 09/01/2009:
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. Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months 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
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:
5.1. 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
5.2. 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
5.3. Concomitant medication that would mean that long-term penicillin is inappropriate
5.4. Diagnostic uncertainty
5.5. Gastrointestinal disease causing persistent diarrhoea or vomiting severe enough to affect the absorption of the phenoxymethylpenicillin
5.6. Allergic diathesis or severe bronchial asthma severe enough to preclude the use of phenoxymethylpenicillin
5.7. Confounding concurrent disease (e.g. deep vein thrombosis [DVT])
6. No access to a telephone
7. Aged less than 16 years
8. Unable to give informed consent
9. Already taking part in a research study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to next episode of cellulites. <br><br>Amended 23/09/10<br>Follow-up duration for primary endpoints 24 months depending on date of recruitment into trial (Duration of follow up was expected to be 12-18 months, at the time of registration)

Secondary Outcome Measures

Name	Time	Method
1. Proportion of participants with repeat episodes of cellulitis<br>2. Proportion of participants with oedema and/or ulceration<br>3. Number of days in hospital for the treatment of repeat episodes of cellulitis<br>4. Number of adverse drug reactions reported in each treatment arm<br>5. Cost-effectiveness, including GP consultations, prescriptions for antibiotics and days in hospital<br>6. Predictors of response multiple regression model to explore the impact of known risk factors in predicting the efficacy of prophylaxis<br>7. Impact of cellulitis on health-related quality of life, assessed using the EuroQol (EQ-5D) and also a measure specific to dermatology (the Dermatology Life Quality Index [DLQI]). <br><br>The time point for each outcome measure will vary with each individual participant but overall they will all be measures throughout the study period which is up to three years from randomisation.