Condition category
Skin and Connective Tissue Diseases
Date applied
25/10/2013
Date assigned
25/10/2013
Last edited
30/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cellulitis is an infection of the skin most often caused by a bacterium called Group A streptococcus. Cellulitis is very common and some people can get it more than once. It can make people feel very ill and cause a lot of skin damage, which can take many weeks to get better. The bacterium produces a variety of poisons or 'toxins' which damage the skin in a similar way to a burn. The normal treatment is with an antibiotic called flucloxacillin, which is effective. Another antibiotic called clindamycin is often used to treat a more serious infection, caused by the same bacterium, called necrotising fasciitis. This antibiotic is also sometimes added to, or used after, flucloxacillin if the cellulitis does not appear to be getting better. Clindamycin is added because some doctors think that it will reduce the amount of toxins released by the bacterium. If less toxin is released then there should be less damage. There is some evidence that adding clindamycin helps the patient. We think that if we add clindamycin to the normal flucloxacillin treatment of cellulitis it might reduce the amount of skin damage. If the amount of skin damage is less then the patient will feel less pain and should recover more quickly. This study should tell us whether adding clindamycin is effective and well tolerated.

Who can participate?
Patients aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb.

What does the study involve?
Patients will be randomly allocated to receive flucloxacillin either with or without clindamycin. We will then see which patients get better more quickly. We will give the patient flucloxacillin as soon as the diagnosis of cellulitis is made, so treatment is not delayed. Clindamycin can sometimes cause diarrhoea so we do not want to give it unless it really does make patients get better quickly.

What are the possible benefits and risks of participating?
Participants will receive appropriate treatment and follow up. There are no extra risks compared with the usual treatments.

Where is the study run from?
Bristol Royal Infirmary and 17 other hospitals in the UK.

When is the study starting and how long is it expected to run for?
From October 2013 to March 2016.

Who is funding the study?
NIHR - Research for Patient Benefit (UK).

Who is the main contact?
Lucy Dixon
Bristol.cellulitis@uhbristol.nhs.uk

Trial website

http://www.bristolcellulitis.org/

Contact information

Type

Scientific

Primary contact

Dr Richard Brindle

ORCID ID

Contact details

Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
-
richard.brindle@uhbristol.nhs.uk

Additional identifiers

EudraCT number

2013-001218-14

ClinicalTrials.gov number

NCT01876628

Protocol/serial number

15297

Study information

Scientific title

Adjunctive Clindamycin for Cellulitis: Clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis (C4C Trial)

Acronym

C4C

Study hypothesis

The aim of this study is to see whether the addition of Clindamycin, a protein inhibiting antibiotic, to the standard antibiotic treatment of limb cellulitis, with Flucloxacillin, results in less tissue damage and a more rapid resolution of both systemic and local features, in a cost-effective manner.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=15297

On 29/04/2015 the overall trial end date was changed from 30/03/2015 to 31/03/2016.

Ethics approval

13/SC/0211; First MREC approval date 11/06/2013

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.bristolcellulitis.org/media/2269570/c4c_patient_information_sheet_v1.4_140904.pdf

Condition

Topic: Injuries and Emergencies, Skin; Subtopic: Injuries and Emergencies (all Subtopics), Skin (all Subtopics); Disease: Injuries and Emergencies, Dermatology

Intervention

Oral clindamycin or placebo added to IV or PO flucloxacillin for 48 hours.

Study Entry : Single Randomisation only

Intervention type

Drug

Phase

Phase IV

Drug names

Clindamycin

Primary outcome measures

Improvement of systemic and local features; Timepoint(s): Day 1 and Day 5

Secondary outcome measures

1. Decrease in pain using a visual analogue score (VAS); Timepoint(s): Day 1, Day 5 and Day 10
2. Quality adjusted life years (QALYs) based on the EQ-5D-5L; Timepoint(s): Day 1 and Day 30
3. Recovery of renal function; Timepoint(s): Day 1, Day 5 and Day 10
4. Resolution of composite inflammatory markers; Timepoint(s): Day 1, Day 5 and Day 10
5. Resolution of systemic features; Timepoint(s): Day 1, Day 5 and Day 10
6. Return to work or normal activities; Timepoint(s): Day 1 and Day 30

Overall trial start date

15/10/2013

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
2. Who are able to understand the study and give consent.
3. Who are able to take oral medication

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 450

Participant exclusion criteria

1. Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy.
2. Patients known to be colonised with MRSA or MRSA isolated from wound within the last year.
3. Unable to take oral medication.
4. Previous history of Clostridium difficile colitis.
5. Clindamycin taken within the last 30 days.
6. Clinically unstable
7. Unable to understand the study or give consent.
8. Any doubt over the certainty of the diagnosis of cellulitis
9. Patients taking any drug that is incompatible with either flucloxacillin or clindamycin

Recruitment start date

15/10/2013

Recruitment end date

30/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Trial participating centre

The Royal London
London
E1 1BB
United Kingdom

Trial participating centre

Royal Devon & Exeter
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Trial participating centre

Yeovil District Hospital
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

Doncaster & Bassetlaw Hospital
Doncaster
DN2 5LT
United Kingdom

Trial participating centre

Basingstoke Hospital
Basingstoke
RG24 9NA
United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Trial participating centre

Poole Hospital
Poole
BH15 2JB
United Kingdom

Trial participating centre

Royal Lancaster Infirmary
Lancaster
LA1 4RP
United Kingdom

Trial participating centre

St George's Hospital
London
SW17 0QT
United Kingdom

Trial participating centre

Manchester Hospital
Manchester
M13 9WL
United Kingdom

Trial participating centre

Royal United Hospital Bath
Bath
BA1 3NG
United Kingdom

Trial participating centre

Newham Hospital
London
E13 8SL
United Kingdom

Trial participating centre

Portsmouth Hospital - Queen Alexandra Hospital
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Northumbria Hospital - North Tyneside General Hospital
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Basildon Hospital
Basildon
SS16 5NL
United Kingdom

Trial participating centre

Leeds General Hospital
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhbristol.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0212-27015

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Molecular studies as soon as possible
2. Results February 2016 BMJ
3. Health economics not known
4. Procalcitonin and inflammatory markers not known

Intention to publish date

01/02/2016

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes