NCT00552799

RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg

Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

To assess whether a period of prophylactic penicillin after an episode of cellulitis of the leg reduces the risk of repeat episodes. Participants are randomised to receive 12 months of prophylaxis (penicillin VK 250mg b.d. or placebo). The PATCH I study will recruit only patients with recurrent disease.

Detailed description

Cellulitis of the leg is an common, acute, painful and potentially serious infection of the skin and subcutaneous tissue. It currently accounts for 2-3% of UK hospital admissions. The average length of in-patient stay is 9 days (Hospital Episode Statistics, Department of Health (UK), 2002-2003) and 25-50% of treated patients suffer further episodes and other morbidity, such as oedema and ulceration. Cellulitis of the lower leg is usually due to streptococcal infection that has entered into the body via a relatively subtle portal, such as toeweb fissures. Penicillin is the most useful of the commonly used oral antibiotics against streptococci, although other agents such as flucloxacillin are often used if staphylococcal infection is a clinical possibility. There are numerous risk factors for cellulitis of the lower leg and recurrent disease is one the biggest problems. Existing evidence for the use of prophylactic antibiotics to prevent further episodes is very limited. Two small randomised controlled trials (RCTs) hint at possible benefit, but these studies are very small (16 and 40 participants respectively). Despite this, many physicians routinely use prophylactic antibiotics for recurrent cellulitis, although opinions on the value of such practice is firmly divided. This study will recruit over a 12-24 month period participants who have completed the therapy for the current episode of cellulitis. Participants will be followed up for up to 24 months with telephone calls at 10 days, 3 months, 6 months, 9 months and 12 months and then every 6 months after completing the intervention. A diary will also be provided as an "aid memoir" to phone calls and to note missed tablets and recurrence of cellulitis.

Conditions

• Cellulitis/Erysipelas of the Leg

Interventions

Type	Name	Description
DRUG	Penicillin VK	Biconcave tablet 250mg oral, b.d.
OTHER	placebo	biconcave tablet matching active comparator as much as possible in size and shape

Timeline

• Start date: 2006-07-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2007-11-02
• Last updated: 2012-07-24

Locations

25 sites across 2 countries: Ireland, United Kingdom