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Adjunctive Clindamycin for Cellulitis: C4C Trial. (C4C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01876628
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : August 17, 2022
Sponsor:
Collaborators:
University of Bristol
Public Health England
Information provided by (Responsible Party):
University Hospitals Bristol and Weston NHS Foundation Trust

Brief 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. This study is a randomised controlled trial comparing Clindamycin with placebo.

Condition or disease Intervention/treatment Phase
Cellulitis Drug: Flucloxacillin Drug: Clindamycin Drug: Placebo oral capsule Phase 4

Detailed Description:

Criteria to be used to assess tissue damage and clinical response:

  1. Fever, tachycardia, neutrophil count, urea and other laboratory parameters at five and ten days post first dose of clindamycin
  2. Limb swelling (by the measurement of limb circumference), skin surface temperature and tissue damage (by the proportion of the limb affected)
  3. Document the duration between initial systemic features and the development of local signs
  4. Examine the effect of the duration between systemic and local features and first dose of flucloxacillin on the subsequent duration and severity of cellulitis
  5. 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
  6. Identify and quantify possible side effects of clindamycin

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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
Placebo Comparator: Flucloxacillin and Placebo oral capsule
Intravenous or oral Flucloxacillin with a Placebo oral capsule
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:
  • Floxapen
  • Fluclomix
  • Ladropen

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
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:
  • Floxapen
  • Fluclomix
  • Ladropen

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:
  • Dalacin C
  • Daclin
  • Cleocin




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Decrease in pain [ Time Frame: Day 10 ]
    Assessed using a visual analogue score

  2. 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.

  3. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
Sponsors and Collaborators
University Hospitals Bristol and Weston NHS Foundation Trust
University of Bristol
Public Health England
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by University Hospitals Bristol and Weston NHS Foundation Trust:
Clindamycin
Cellulitis
Flucloxacillin
Group A streptococcus
Staphylococcus aureus
Additional relevant MeSH terms:
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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