Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis
Identifieur interne : 003B82 ( Pmc/Curation ); précédent : 003B81; suivant : 003B83Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis
Auteurs : Richard Brindle [Royaume-Uni] ; O Martin Williams [Royaume-Uni] ; Paul Davies [Royaume-Uni] ; Tim Harris [Royaume-Uni] ; Heather Jarman [Royaume-Uni] ; Alastair D. Hay [Royaume-Uni] ; Peter Featherstone [Royaume-Uni]Source :
- BMJ Open [ 2044-6055 ] ; 2017.
Abstract
To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis.
Parallel, double-blinded, randomised controlled trial.
Emergency department attendances and general practice referrals within 20 hospitals in England.
Flucloxacillin, at a minimum of 500 mg 4 times per day for 5 days, with clindamycin 300 mg 4 times per day for 2 days given orally versus flucloxacillin given alone.
The primary outcome was improvement at day 5. This was defined as being afebrile with either a reduction in affected skin surface temperature or a reduction in the circumference of the affected area. Secondary outcomes included resolution of systemic features, resolution of inflammatory markers, recovery of renal function, reduction in the affected area, decrease in pain, return to work or normal activities and the absence of increased side effects.
410 patients were included in the trial. No significant difference was seen in improvement at day 5 for flucloxacillin with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172, 81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant difference in the number of patients with diarrhoea at day 5 in the flucloxacillin with clindamycin allocation (34/160, 22%) versus flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002. There was no clinically significant difference in any secondary outcome measures. There was no significant difference in the number of patients stating that they had returned to normal activities at the day 30 interview in the flucloxacillin with clindamycin allocation (99/121, 82%) versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44 to 1.84).
The addition of a short course of clindamycin to flucloxacillin early on in limb cellulitis does not improve outcome. The addition of clindamycin doubles the likelihood of diarrhoea within the first few days.
Url:
DOI: 10.1136/bmjopen-2016-013260
PubMed: 28314743
PubMed Central: 5372109
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<front><div type="abstract" xml:lang="en"><sec><title>Objective</title>
<p>To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis.</p>
</sec>
<sec><title>Design</title>
<p>Parallel, double-blinded, randomised controlled trial.</p>
</sec>
<sec><title>Setting</title>
<p>Emergency department attendances and general practice referrals within 20 hospitals in England.</p>
</sec>
<sec><title>Interventions</title>
<p>Flucloxacillin, at a minimum of 500 mg 4 times per day for 5 days, with clindamycin 300 mg 4 times per day for 2 days given orally versus flucloxacillin given alone.</p>
</sec>
<sec><title>Main outcome measures</title>
<p>The primary outcome was improvement at day 5. This was defined as being afebrile with either a reduction in affected skin surface temperature or a reduction in the circumference of the affected area. Secondary outcomes included resolution of systemic features, resolution of inflammatory markers, recovery of renal function, reduction in the affected area, decrease in pain, return to work or normal activities and the absence of increased side effects.</p>
</sec>
<sec><title>Results</title>
<p>410 patients were included in the trial. No significant difference was seen in improvement at day 5 for flucloxacillin with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172, 81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant difference in the number of patients with diarrhoea at day 5 in the flucloxacillin with clindamycin allocation (34/160, 22%) versus flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002. There was no clinically significant difference in any secondary outcome measures. There was no significant difference in the number of patients stating that they had returned to normal activities at the day 30 interview in the flucloxacillin with clindamycin allocation (99/121, 82%) versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44 to 1.84).</p>
</sec>
<sec><title>Conclusions</title>
<p>The addition of a short course of clindamycin to flucloxacillin early on in limb cellulitis does not improve outcome. The addition of clindamycin doubles the likelihood of diarrhoea within the first few days.</p>
</sec>
<sec><title>Trial registration number</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01876628">NCT01876628</ext-link>
, Results.</p>
</sec>
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<article-id pub-id-type="doi">10.1136/bmjopen-2016-013260</article-id>
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</subj-group>
</subj-group>
<subj-group subj-group-type="hwp-journal-coll"><subject>1506</subject>
<subject>1706</subject>
<subject>1687</subject>
</subj-group>
</article-categories>
<title-group><article-title>Adjunctive clindamycin for cellulitis: a clinical trial comparing flucloxacillin with or without clindamycin for the treatment of limb cellulitis</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Brindle</surname>
<given-names>Richard</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Williams</surname>
<given-names>O Martin</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Davies</surname>
<given-names>Paul</given-names>
</name>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Harris</surname>
<given-names>Tim</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Jarman</surname>
<given-names>Heather</given-names>
</name>
<xref ref-type="aff" rid="af4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Hay</surname>
<given-names>Alastair D</given-names>
</name>
<xref ref-type="aff" rid="af5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Featherstone</surname>
<given-names>Peter</given-names>
</name>
<xref ref-type="aff" rid="af6">6</xref>
</contrib>
</contrib-group>
<aff id="af1"><label>1</label>
<addr-line>Microbiology and Infectious Diseases</addr-line>
,<institution>Bristol Royal Infirmary</institution>
,<addr-line>Bristol</addr-line>
,<country>UK</country>
</aff>
<aff id="af2"><label>2</label>
<addr-line>General Practice Support Unit</addr-line>
,<institution>Bristol Royal Infirmary</institution>
,<addr-line>Bristol</addr-line>
,<country>UK</country>
</aff>
<aff id="af3"><label>3</label>
<addr-line>Department of Emergency Medicine</addr-line>
,<institution>Royal London Hospital</institution>
,<addr-line>London</addr-line>
,<country>UK</country>
</aff>
<aff id="af4"><label>4</label>
<addr-line>Department of Emergency Medicine</addr-line>
,<institution>St George's University Hospitals</institution>
,<addr-line>London</addr-line>
,<country>UK</country>
</aff>
<aff id="af5"><label>5</label>
<addr-line>Centre for Academic Primary Care</addr-line>
,<institution>University of Bristol</institution>
,<addr-line>Bristol</addr-line>
,<country>UK</country>
</aff>
<aff id="af6"><label>6</label>
<addr-line>Acute Medicine Unit</addr-line>
,<institution>Queen Alexandra Hospital</institution>
,<addr-line>Portsmouth</addr-line>
,<country>UK</country>
</aff>
<author-notes><corresp><label>Correspondence to</label>
Dr Richard Brindle; <email>brindlri@carpha.org</email>
</corresp>
</author-notes>
<pub-date pub-type="collection"><year>2017</year>
</pub-date>
<pub-date pub-type="epub"><day>17</day>
<month>3</month>
<year>2017</year>
</pub-date>
<volume>7</volume>
<issue>3</issue>
<elocation-id>e013260</elocation-id>
<history><date date-type="received"><day>29</day>
<month>6</month>
<year>2016</year>
</date>
<date date-type="rev-recd"><day>23</day>
<month>11</month>
<year>2016</year>
</date>
<date date-type="accepted"><day>21</day>
<month>12</month>
<year>2016</year>
</date>
</history>
<permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/</copyright-statement>
<copyright-year>2017</copyright-year>
<license license-type="open-access"><license-p>This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>
</license-p>
</license>
</permissions>
<self-uri xlink:title="pdf" xlink:href="bmjopen-2016-013260.pdf"></self-uri>
<abstract><sec><title>Objective</title>
<p>To compare flucloxacillin with clindamycin to flucloxacillin alone for the treatment of limb cellulitis.</p>
</sec>
<sec><title>Design</title>
<p>Parallel, double-blinded, randomised controlled trial.</p>
</sec>
<sec><title>Setting</title>
<p>Emergency department attendances and general practice referrals within 20 hospitals in England.</p>
</sec>
<sec><title>Interventions</title>
<p>Flucloxacillin, at a minimum of 500 mg 4 times per day for 5 days, with clindamycin 300 mg 4 times per day for 2 days given orally versus flucloxacillin given alone.</p>
</sec>
<sec><title>Main outcome measures</title>
<p>The primary outcome was improvement at day 5. This was defined as being afebrile with either a reduction in affected skin surface temperature or a reduction in the circumference of the affected area. Secondary outcomes included resolution of systemic features, resolution of inflammatory markers, recovery of renal function, reduction in the affected area, decrease in pain, return to work or normal activities and the absence of increased side effects.</p>
</sec>
<sec><title>Results</title>
<p>410 patients were included in the trial. No significant difference was seen in improvement at day 5 for flucloxacillin with clindamycin (136/156, 87%) versus flucloxacillin alone (140/172, 81%)—OR 1.55 (95% CI 0.81 to 3.01), p=0.174. There was a significant difference in the number of patients with diarrhoea at day 5 in the flucloxacillin with clindamycin allocation (34/160, 22%) versus flucloxacillin alone (16/176, 9%)—OR 2.7 (95% CI 1.41 to 5.07), p=0.002. There was no clinically significant difference in any secondary outcome measures. There was no significant difference in the number of patients stating that they had returned to normal activities at the day 30 interview in the flucloxacillin with clindamycin allocation (99/121, 82%) versus flucloxacillin alone (104/129, 81%)—adjusted OR 0.90 (95% CI 0.44 to 1.84).</p>
</sec>
<sec><title>Conclusions</title>
<p>The addition of a short course of clindamycin to flucloxacillin early on in limb cellulitis does not improve outcome. The addition of clindamycin doubles the likelihood of diarrhoea within the first few days.</p>
</sec>
<sec><title>Trial registration number</title>
<p><ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01876628">NCT01876628</ext-link>
, Results.</p>
</sec>
</abstract>
<kwd-group><kwd>cellulitis</kwd>
<kwd>erysipelas</kwd>
<kwd>flucloxacillin</kwd>
<kwd>clindamycin</kwd>
<kwd>limb</kwd>
<kwd>diarrhoea</kwd>
</kwd-group>
<funding-group specific-use="FundRef"><award-group id="funding-1"><funding-source><institution-wrap><institution>National Institute for Health Research</institution>
<institution-id>http://dx.doi.org/10.13039/501100000272</institution-id>
</institution-wrap>
</funding-source>
<award-id>PB-PG-0212-27015</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
</record>
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