RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00552799|
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : July 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis/Erysipelas of the Leg||Drug: Penicillin VK Other: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Penicillin VK 250 mg b.d.
Drug: Penicillin VK
Biconcave tablet 250mg oral, b.d.
Placebo Comparator: 2
placebo tablet b.d.
biconcave tablet matching active comparator as much as possible in size and shape
- The primary outcome is time to next episode of cellulitis [ Time Frame: variable ]
- Secondary outcomes include: i) the proportion of participants with repeat episodes of cellulitis; ii) proportion of participants with oedema and/or ulceration; iii) cost-effectiveness; iv) predictors of response (multiple regression model). [ Time Frame: variable ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552799
|Study Director:||Hywel Williams, Professor||University of Nottingham|