NCT01876628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2.2 years

First QC Date

June 10, 2013

Last Update Submit

August 16, 2022

Conditions

Cellulitis

Keywords

ClindamycinCellulitisFlucloxacillinGroup A streptococcusStaphylococcus aureus

Outcome Measures

Primary Outcomes (1)

  • 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

    Day 5

Secondary Outcomes (3)

  • Decrease in pain

    Day 10

  • Quality of life

    Day 30

  • Physiological recovery

    Day 10

Study Arms (2)

Flucloxacillin and Placebo oral capsule

PLACEBO COMPARATOR

Intravenous or oral Flucloxacillin with a Placebo oral capsule

Drug: FlucloxacillinDrug: Placebo oral capsule

Flucloxacillin and Clindamycin

ACTIVE COMPARATOR

Intravenous or oral Flucloxacillin with Clindamycin oral capsule

Drug: FlucloxacillinDrug: Clindamycin

Interventions

FlucloxacillinDRUG

Intravenous or oral Flucloxacillin. Minimum dose 500mg four times each day. Target duration 5 days less pre-recruitment beta-lactam duration.

Also known as: Floxapen, Fluclomix, Ladropen
Flucloxacillin and ClindamycinFlucloxacillin and Placebo oral capsule
ClindamycinDRUG

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.

Also known as: Dalacin C, Daclin, Cleocin
Flucloxacillin and Clindamycin
Placebo oral capsuleDRUG

Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days

Flucloxacillin and Placebo oral capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Bristol NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28314743DERIVED

MeSH Terms

Conditions

CellulitisStaphylococcal Infections

Interventions

FloxacillinClindamycin

Condition Hierarchy (Ancestors)

Skin Diseases, InfectiousInfectionsSuppurationConnective Tissue DiseasesSkin and Connective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

CloxacillinOxacillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Locations

GB(1)