CellulitisPhase 4C4CNCT01876628
Adjunctive Clindamycin for Cellulitis: C4C Trial.
A Phase 4 study testing Flucloxacillin and Clindamycin in people with Cellulitis, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cellulitis
- What is being tested?
- Flucloxacillin and Clindamycin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
- Who are able to understand the study and give consent
- Who are able to take oral medication
Who cannot join
- Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
- Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year
- Patients unable to take oral medication
- Previous history of Clostridium difficile colitis
- Clindamycin taken within the last 30 days
- Clinically unstable
Show all 10Show fewer
- Unable to understand the study or give consent
- Any doubt over the certainty of the diagnosis of cellulitis
- Patients taking any drug that is incompatible with either flucloxacillin or clindamycin
- Pre-existing diarrhoea
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW
About this study
Official title: A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis
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. This study is a randomised controlled trial comparing Clindamycin with placebo.
Read the detailed description
Criteria to be used to assess tissue damage and clinical response:
- Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
- Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
- Document the duration between initial systemic features and the development of local signs
- Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
- Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis
- Identify and quantify possible side effects of clindamycin
- Conditions
- Cellulitis
- Being tested
- Flucloxacillin, Clindamycin, Placebo oral capsule
- Keywords
- Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus
- Medical subject headings
- Cellulitis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucloxacillinDrug
Also called Floxapen, Fluclomix, Ladropen
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
ClindamycinDrug
Also called Dalacin C, Daclin, Cleocin
Clindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo.
Placebo oral capsuleDrug
Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Flucloxacillin and Placebo oral capsule | Placebo comparator | Intravenous or oral Flucloxacillin with a Placebo oral capsule Receives: Drug: Flucloxacillin; Drug: Placebo oral capsule |
| Flucloxacillin and Clindamycin | Active comparator | Intravenous or oral Flucloxacillin with Clindamycin oral capsule Receives: Drug: Flucloxacillin; Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement based on a composite of systemic and local features
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature
Measured: Day 5
Secondary outcomes (3)
Decrease in pain
Assessed using a visual analogue score
Measured: Day 10
Quality of life
Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
Measured: Day 30
Physiological recovery
Resolution of systemic features, composite inflammatory markers and recovery of renal function.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CellulitisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol, Public Health England
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876628
- Sponsor's protocol ID
- C4C-4078
- Other IDs
- 2013-001218-14
- Acronym
- C4C
- Status last verified
- Aug 2022
- First submitted
- 10 Jun 2013
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Brindle R, Williams OM, Davies P, Harris T, Jarman H, Hay AD, Featherstone P. Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis. BMJ Open. 2017 Mar 17;7(3):e013260. doi: 10.1136/bmjopen-2016-013260.
PubMed 28314743
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Control Trial to Measure the Effect of the Addition of Clindamycin to Flucloxacillin for the Treatment of Limb Cellulitis
- ClinicalTrials.gov ID
- NCT01876628
- Acronym / sponsor ID
- C4C / C4C-4078
- Conditions
- Cellulitis
- Keywords
- Clindamycin, Cellulitis, Flucloxacillin, Group A streptococcus, Staphylococcus aureus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bristol, Public Health England
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jun 2013 (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.
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. This study is a randomised controlled trial comparing Clindamycin with placebo.
Detailed description
Criteria to be used to assess tissue damage and clinical response:
- Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
- Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
- Document the duration between initial systemic features and the development of local signs
- Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
- Examine the effect of duration between the first dose of flucloxacillin and the first dose of clindamycin on the subsequent duration and severity of cellulitis
- Identify and quantify possible side effects of clindamycin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flucloxacillin and Placebo oral capsule | Placebo comparator | Drug: Flucloxacillin, Drug: Placebo oral capsuleIntravenous or oral Flucloxacillin with a Placebo oral capsule |
| Flucloxacillin and Clindamycin | Active comparator | Drug: Flucloxacillin, Drug: ClindamycinIntravenous or oral Flucloxacillin with Clindamycin oral capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged 18 or over who have a diagnosis of cellulitis of a single, upper or lower, limb
- Who are able to understand the study and give consent
- Who are able to take oral medication
Key exclusion criteria (10 listed)
- Patients with a confirmed history of penicillin, flucloxacillin or clindamycin allergy
- Patients known to be colonised with Methicillin-resistant Staphylococcus aureus or Methicillin-resistant Staphylococcus aureus isolated from wound within the last year
- Patients unable to take oral medication
- Previous history of Clostridium difficile colitis
- Clindamycin taken within the last 30 days
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 |
|---|---|---|
| FlucloxacillinAlso: Floxapen, Fluclomix, LadropenIntravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration. | Drug | Flucloxacillin and Clindamycin, Flucloxacillin and Placebo oral capsule |
| ClindamycinAlso: Dalacin C, Daclin, CleocinClindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo. | Drug | Flucloxacillin and Clindamycin |
| Placebo oral capsulePlacebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days | Drug | Flucloxacillin and Placebo oral capsule |
Primary outcome
Improvement based on a composite of systemic and local features
Time frame: Day 5
Temperature less than 37.5 degrees centigrade, reduction in limb swelling and reduction in skin temperature
3 secondary outcomes
Decrease in pain
Time frame: Day 10
Quality of life
Time frame: Day 30
Physiological recovery
Time frame: Day 10
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 17 Aug 2022.
- Derived from this study: PubMed 28314743Brindle R, Williams OM, Davies P, Harris T, Jarman H, Hay AD, Featherstone P. Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis. BMJ Open. 2017 Mar 17;7(3):e013260. doi: 10.1136/bmjopen-2016-013260.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flucloxacillin and Clindamycin in people with Cellulitis, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 10 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Improvement based on a composite of systemic and local features (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876628, which also lists 1 linked publication.
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 17 Aug 2022.