Oral flucloxacillin and phenoxymethylpenicillin versus flucloxacillin alone for the emergency department outpatient treatment of cellulitis: Study protocol for a randomised controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Quirke, Michael ^a   Wakai, Abel ^a   Gilligan, Peadar ^b   O'Sullivan, Ronan ^c,d  

^a ROYAL COLLEGE OF SURGEONS IN IRELAND   (Ireland)

^b BEAUMONT HOSPITAL   (Ireland)

^c NATIONAL CHILDREN S RESEARCH CENTRE   (Ireland)

^d Department of Medicine National University of Ireland Cork   (Ireland)

Author keywords

Adult; Cellulitis; Double blind; Emergency department; Flucloxacillin; Oral; Penicillin V; Phenoxymethylpenicillin; Randomised controlled trial

Indexed keywords

FLUCLOXACILLIN; PENICILLIN V; PLACEBO;

ADOLESCENT; ADULT; ADVERSE OUTCOME; ARTICLE; CELLULITIS; CLINICAL PROTOCOL; COMBINATION CHEMOTHERAPY; COMORBIDITY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; EMERGENCY CARE; FEMALE; FOLLOW UP; HUMAN; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; OUTPATIENT CARE; PATIENT COMPLIANCE; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCORING SYSTEM; SHORT FORM 36; SKIN AND SOFT TISSUE INFECTION; SKIN INFECTION; SOFT TISSUE INFECTION; TELEPHONE; TREATMENT DURATION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ADMINISTRATION, ORAL; AMBULATORY CARE; ANTI-BACTERIAL AGENTS; CELLULITIS; CLINICAL PROTOCOLS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EMERGENCY SERVICE, HOSPITAL; FLOXACILLIN; HUMANS; IRELAND; MEDICATION ADHERENCE; PENICILLIN V; QUALITY OF LIFE; QUESTIONNAIRES; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME;

EID: 84878359662     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-164     Document Type: Article

References (24)

1. Kilburn S, Featherstone P, Higgins B, Brindle R. Interventions for cellulitis and erysipelas. Cochrane Database Syst Rev 2010, 16. CD004299.
2. Hay RJ, Adriaans BM. Bacterial Infections. Rook's Textbook of Dermatology. Volume 2 2004, 27. Oxford: Blackwell Publishing, Burns DA, Breathnach SM, Cox NH, Griffiths C, 7, 16-27.20.
3. Gunderson CG. Cellulitis: definition, etiology and clinical features. Am J Med 2011, 124:1113-1122. 10.1016/j.amjmed.2011.06.028, 22014791.
4. The Economic and Social Research Institute (ESRI) http://www.esri.ie/health_information/hipe_data_reporter/prepare_report/report.xml.
5. CREST (Clinical Resource Efficiency Support Team) Section 1; Introduction. CREST guidelines on the management of cellulitis in adults 2005, 1-31. DHSS Northern Ireland, CREST, CREST (Clinical Resource Efficiency Support Team).
6. Hospital Episode Statistics http://www.hesonline.nhs.uk/.
7. Goettsch WG, Bouwes Bavinck JN, Herings RMC. Burden of illness of bacterial cellulitis and erysipelas of the leg in the Netherlands. JEADV 2006, 20:834-839.
8. Hersh AL, Chambers HF, Maselli JH, Gonzales R. National trends in ambulatory visits and antibiotic prescribing for skin and soft-tissue infections. Arch Int Med 2008, 168:1585-1591.
9. Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis 2007, 13:1840-1846. 10.3201/eid1312.070629, 2876761, 18258033.
10. Dryden MS. Skin and soft tissue infection: microbiology and epidemiology. Int J Antimicrob Agents 2009, 34(Suppl 1):S2-S7.
11. Chira S, Miller LG. Staphylococcus aureus is the most common identified cause of cellulitis: a systematic review. Epidemiol Infect 2010, 138:313-317. 10.1017/S0950268809990483, 19646308.
12. Schöfer H, Bruns R, Effendy I, Hartmann M, Jappe U, Plettenberg A, Reimann H, Seifert H, Shah P, Sunderkötter C, Weberschock T, Wichelhaus TA, Nast A, German Society of Dermatology (DDG)/ Professional Association of German Dermatologists (BVDD); Infectious Diseases Society of Germany (DGI); German Society for Hygiene and Microbiology (DGHM); German Society for Pediatric Infectious Diseases (DGPI); Paul Ehrlich Society for Chemotherapy (PEG) Diagnosis and treatment of Staphylococcus aureus infections of the skin and mucous membranes. J Deutsch Dermatol Ges 2011, 9:953-967. German Society of Dermatology (DDG)/ Professional Association of German Dermatologists (BVDD); Infectious Diseases Society of Germany (DGI); German Society for Hygiene and Microbiology (DGHM); German Society for Pediatric Infectious Diseases (DGPI); Paul Ehrlich Society for Chemotherapy (PEG).
13. PRODIGY Acute cellulitis 2011, http://prodigy.clarity.co.uk/cellulitis_acute/view_whole_topic, PRODIGY.
14. [Management of erysipelas and necrotising fasciitis] Article in French. Ann Dermatol Venereol 2001, 128:458-462.
15. Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF, Infectious Diseases Society of America Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011, 52:e18-e55. 10.1093/cid/ciq146, 21208910, Infectious Diseases Society of America.
16. Eron LJ, Lipsky BA, Low DE, Nathwani D, Tice AD, Volturo GA. Managing skin and soft tissue infections: expert panel recommendations on key decision points. J Antimicrob Chemother 2003, 52(Suppl 1):i3-i17.
17. Guidelines for the management of cellulitis in adults in the community http://www.legacy.solihull.nhs.uk/getmedia/4c233899-273e-45cd-8851-c8cc661c5eb6/SCT(C)275v3.2010---Guidelines-for-the-management-of-cellulitis-in-adults-in-the-community.aspx.
18. Leman P, Mukherjee D. Flucloxacillin alone or combined with benzylpenicillin to treat lower limb cellulitis: a randomised controlled trial. Emerg Med J 2005, 22:342-346. 10.1136/emj.2004.019869, 1726763, 15843702.
19. Cox NH. Management of lower leg cellulitis. Clin Med 2002, 2:23-27. 10.7861/clinmedicine.2-1-23, 11871634.
20. Anonymous Dilemmas when managing cellulitis. Drug Ther Bull 2003, 41:43-46. Anonymous.
21. Morris A. Cellulitis and erysipelas. Clin Evid 2002, 7:1483-1487. Update in: Clin Evid 2003, 9:1804-1809.
22. British Medical Association and the Royal Pharmaceutical Society of Great Britain British National Formulary 2009, London, UK: BMJ Publishing Group, 58, British Medical Association and the Royal Pharmaceutical Society of Great Britain.
23. Thomas K, Crook A, Foster K, Mason J, Chalmers J, Bourke J, Ferguson A, Level N, Nunn A, Williams H, UK Dermatology Clinical Trials Network's PATCH Trial Team Prophylactic antibiotics for the prevention of cellulitis (erysipelas) of the leg: results of the UK Dermatology Clinical Trials Network's PATCH II trial. Br J Dermatol 2012, 166:169-178. 3494300, 21910701, UK Dermatology Clinical Trials Network's PATCH Trial Team.
24. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med 2003, 22:169-186.