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Search / Trial NCT02922686

Penicillin for the Emergency Department Outpatient Treatment of CELLulitis

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Sep 30, 2016

Trial Information

Current as of May 15, 2025

Unknown status

Keywords

ClinConnect Summary

There is obvious clinical equipoise between the use of oral flucloxacillin alone or combined with phenoxymethylpenicillin for the emergency department treatment of cellulitis, wound infections and abscesses as evidenced by current disparate prescribing practice and hospital guidelines. Feasibility studies for the planned trial have shown that 45-50% of emergency department patients with these infections in Ireland are discharged on oral antibiotics which is consistent with findings in other jurisdictions. Despite the significant healthcare and economic costs associated with cellulitis, ther...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Clinically diagnosed cellulitis, wound infections or abscess (ABSSSI) affecting any body part, excluding the perineum, and having any two of the following signs:
  • Erythema
  • Warmth
  • Tenderness / Pain of affected area
  • Oedema / Induration
  • Regional lymphadenopathy
  • Cellulitis, wound infection and abscess deemed treatable with oral outpatient antibiotics in which either combination of antibiotic is likely to produce a clinical response (Eron Class 1-2)
  • Written informed consent obtained.
  • 16 years of age or older.
  • Fluency in written and spoken English.
  • Willing to return for study follow-up or to have the research nurse visit their home.
  • Willing to receive a telephone call from a study investigator.
  • Exclusion Criteria:
  • Penicillin allergy (self-reported or confirmed).
  • Any cellulitis, wound infection and abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
  • Any cellulitis, wound infection and abscess that is more severe than Eron Class 2 (Appendix 2)
  • Any cellulitis, wound infection and abscess of the perineal region.
  • Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection or abscess
  • Any medical condition, based on clinical judgment, that may interfere with interpretation of the primary outcome measures (e.g. chronic skin condition at the lesion site)
  • Immunodeficiency from primary or secondary causes (e.g. corticosteroids, chemotherapeutic agents).
  • Previous history of renal dysfunction or known chronic kidney disease under care of a nephrologist. - Previous history of liver dysfunction defined as chronically deranged liver function tests elicited from medical notes or history.
  • Suspected or confirmed septic arthritis.
  • Suspected or confirmed osteomyelitis.
  • Infection involving prosthetic material.
  • Pregnant or lactating women.
  • Patients with a previous history of flucloxacillin- associated jaundice/hepatic dysfunction
  • Patients with a previous history of MRSA colonization/infection.
  • Patients with lactose intolerance diagnosed by a medical professional

About Royal College Of Surgeons, Ireland

The Royal College of Surgeons in Ireland (RCSI) is a prestigious educational and research institution dedicated to advancing surgical practice and healthcare through innovative research, education, and clinical excellence. As a clinical trial sponsor, RCSI plays a pivotal role in conducting cutting-edge research that aims to improve surgical outcomes and patient care. With a commitment to fostering collaboration among healthcare professionals, researchers, and industry partners, RCSI is at the forefront of developing evidence-based interventions and therapies that address critical health challenges. Through its rigorous scientific approach and adherence to ethical standards, RCSI strives to contribute significantly to the advancement of medical knowledge and the enhancement of surgical practices globally.

Locations

Blanchardstown, Dublin, Ireland

Cork, Greenville Place, Ireland

Cork, Wilton, Ireland

Dublin, , Ireland

Dublin, , Ireland

Patients applied

0 patients applied

Trial Officials

Adrian Moughty

Principal Investigator

Mater Misericordiae University Hospital

Joseph McKeever

Principal Investigator

Connolly Hospital Blanchardstown

Conor Deasy

Principal Investigator

Department of Emergency Medicine, Cork University Hopsital, Cork

Chris Luke

Principal Investigator

Department of Emergency Medicine, Mercy University, Cork

Abel Wakai, MD FRCEM

Principal Investigator

Department of Emergency Medicine, Beaumont Hospital, Dublin

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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