Adjunctive Clindamycin for Cellulitis: C4C Trial. (C4C)
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ClinicalTrials.gov Identifier: NCT01876628 |
Recruitment Status :
Completed
First Posted : June 12, 2013
Last Update Posted : August 17, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cellulitis | Drug: Flucloxacillin Drug: Clindamycin Drug: Placebo oral capsule | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 410 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | March 2016 |

Arm | Intervention/treatment |
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Placebo Comparator: Flucloxacillin and Placebo oral capsule
Intravenous or oral Flucloxacillin with a Placebo oral capsule
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Drug: Flucloxacillin
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
Other Names:
Drug: Placebo oral capsule Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days |
Active Comparator: Flucloxacillin and Clindamycin
Intravenous or oral Flucloxacillin with Clindamycin oral capsule
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Drug: Flucloxacillin
Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.
Other Names:
Drug: Clindamycin 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.
Other Names:
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- 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
- Decrease in pain [ Time Frame: Day 10 ]Assessed using a visual analogue score
- Quality of life [ Time Frame: Day 30 ]Assessment based on a questionnaire plus return to work or normal activities and absence of increased side-effects.
- Physiological recovery [ Time Frame: Day 10 ]Resolution of systemic features, composite inflammatory markers and recovery of renal function.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

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): NCT01876628
United Kingdom | |
University Hospitals Bristol NHS Foundation Trust | |
Bristol, United Kingdom, BS2 8HW |
Responsible Party: | University Hospitals Bristol and Weston NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT01876628 |
Other Study ID Numbers: |
C4C-4078 2013-001218-14 ( EudraCT Number ) |
First Posted: | June 12, 2013 Key Record Dates |
Last Update Posted: | August 17, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Clindamycin Cellulitis Flucloxacillin Group A streptococcus Staphylococcus aureus |
Cellulitis Skin Diseases, Infectious Infections Suppuration Connective Tissue Diseases Inflammation Pathologic Processes Clindamycin |
Clindamycin palmitate Clindamycin phosphate Floxacillin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |