Cellulitis/Erysipelas of the LegPhase 4PATCH1NCT00552799
RCT to Investigate if Prophylactic Antibiotics Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg
A Phase 4 study testing Penicillin VK in people with Cellulitis/Erysipelas of the Leg, run by University of Nottingham at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cellulitis/Erysipelas of the Leg
- What is being tested?
- Penicillin VK
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jul 2006to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of cellulitis of either leg AND a history of at least one previous episode of cellulitis of either leg within the three
Who cannot join
- 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:
- Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode.
- 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.
- Known allergy to penicillin.
- 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).
- Treating physician or principal investigator unwilling to randomise patient. This includes, but is not limited to:
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- 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.
- 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
- Concomitant medication that would mean that long-term penicillin is inappropriate
- Diagnostic uncertainty
- Gastrointestinal disease causing persistent diarrhoea or vomiting severe enough to affect the absorption of the phenoxymethylpenicillin.
- Allergic diathesis or severe bronchial asthma severe enough to preclude the use of phenoxymethylpenicillin.
- Confounding concurrent disease (e.g. DVT).
- No access to a telephone.
- Aged less than 16 years.
- Unable to give informed consent.
- Already taking part in a research study.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United Kingdom24 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Amersham Hospital
Amersham, HP7 0JD
Brighton General Hospital
Brighton, BN2 3EW
Bristol Royal Infirmary
Bristol, BS2 8HW
Cumberland Infirmary
Carlisle, CA2 7HY
Derbyshire Royal Infirmary
Derby, DE1 2QY
University Hospital of North Durham
Durham, DE1 5TW
Gloucestershire Royal Infirmary
Gloucester, GL1 3NN
James Paget University Hospital
Great Yarmouth, NR31 6LA
Princess Royal Hospital
Hull, HU8 9HE
Ipswich Hospital
Ipswich, IP4 5HD
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET
Leicester Royal Infirmary
Leicester, LE1 5WW
Broadgreen Hospital
Liverpool, L14 3LB
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
Royal Berkshire Hospital
Reading, RG1 5AN
Hope Hospital
Salford, M6 8HD
King's Mill Hospital
Sutton in Ashfield, NG17 4JL
Singleton Hospital
Swansea, SA2 8QA
Watford General Hospital
Watford, WD1 8HB
York Hospital
York, YO31 8HR
About this study
Official title: Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
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.
Read the 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
- Being tested
- Penicillin VK, placebo
- Keywords
- cellulitis, lymphoedema, penicillin, clinical trial
- Medical subject headings
- Cellulitis, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penicillin VKDrug
Biconcave tablet 250mg oral, b.d.
placeboOther
biconcave tablet matching active comparator as much as possible in size and shape
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Penicillin VK 250 mg b.d. Receives: Drug: Penicillin VK |
| 2 | Placebo comparator | placebo tablet b.d. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is time to next episode of cellulitis
Measured: variable
Secondary outcomes (1)
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).
Measured: variable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJul 2006
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cellulitis/Erysipelas of the LegStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Action Medical Research, UK Dermatology Clinical Trials Network
- Responsible party
- Sponsor
- Investigators
- Hywel Williams, Professor, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552799
- Sponsor's protocol ID
- 06002
- Other IDs
- ISRCTN34716921, EudraCT No. 2006-000381-36
- Acronym
- PATCH1
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 2007
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Investigate Whether Prophylactic Antibiotics Can Prevent Further Episodes of Cellulitis (Erysipelas) of the Leg (PATCH I)
- ClinicalTrials.gov ID
- NCT00552799
- Acronym / sponsor ID
- PATCH1 / 06002
- Conditions
- Cellulitis/Erysipelas of the Leg
- Keywords
- cellulitis, lymphoedema, penicillin, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Action Medical Research, UK Dermatology Clinical Trials Network
- Study start
- Jul 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Penicillin VKPenicillin VK 250 mg b.d. |
| 2 | Placebo comparator | Other: placeboplacebo tablet b.d. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of cellulitis of either leg AND a history of at least one previous episode of cellulitis of either leg within the three
Key exclusion criteria (17 listed)
- 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:
- Taken antibiotic prophylaxis (defined as more than 3 months usage) for the prevention of cellulitis within 6 months prior to index episode.
- 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.
- Known allergy to penicillin.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penicillin VKBiconcave tablet 250mg oral, b.d. | Drug | 1 |
| placebobiconcave tablet matching active comparator as much as possible in size and shape | Other | 2 |
Primary outcome
The primary outcome is time to next episode of cellulitis
Time frame: variable
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hywel Williams, Professor study director
University of Nottingham
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Penicillin VK in people with Cellulitis/Erysipelas of the Leg, run by University of Nottingham at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is time to next episode of cellulitis (time frame: variable). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.