Adjunctive Clindamycin For Cellulitis clinical trial (C4C)
| ISRCTN | ISRCTN86329346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86329346 |
| EudraCT/CTIS number | 2013-001218-14 |
| ClinicalTrials.gov number | NCT01876628 |
| Secondary identifying numbers | 15297 |
- Submission date
- 25/10/2013
- Registration date
- 25/10/2013
- Last edited
- 15/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
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?
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
Contact information
Scientific
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| richard.brindle@uhbristol.nhs.uk |
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.bristolcellulitis.org/media/2269570/c4c_patient_information_sheet_v1.4_140904.pdf |
| Scientific title | Adjunctive Clindamycin for Cellulitis: Clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis (C4C Trial) |
| Study 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. |
| Ethics approval(s) | 13/SC/0211; First MREC approval date 11/06/2013 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Clindamycin |
| Primary outcome measure | 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 study start date | 15/10/2013 |
| Overall study end date | 31/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 450 |
| 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 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
- England
- United Kingdom
Study participating centres
BS2 8HW
United Kingdom
E1 1BB
United Kingdom
EX2 5DW
United Kingdom
HU3 2JZ
United Kingdom
BA21 4AT
United Kingdom
DN2 5LT
United Kingdom
RG24 9NA
United Kingdom
SE5 9RS
United Kingdom
BH15 2JB
United Kingdom
LA1 4RP
United Kingdom
SW17 0QT
United Kingdom
M13 9WL
United Kingdom
BA1 3NG
United Kingdom
E13 8SL
United Kingdom
PO6 3LY
United Kingdom
NE29 8NH
United Kingdom
SS16 5NL
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
| Website | http://www.uhbristol.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/03/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/05/2018: Publication reference added.
29/04/2015: The overall trial end date was changed from 30/03/2015 to 31/03/2016.
