Clinical trial of one antibiotic (flucloxacillin) versus two antibiotics (flucloxacillin and phenoxymethylpenicillin) for the Emergency department treatment of skin infections

Phase 1

• Conditions: Skin Infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-001528-69-IE
• Lead Sponsor: Royal College of Surgeons in Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-10
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Clinically diagnosed cellulitis, wound infection & abscess 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
•Purulent drainage
2.Cellulitis, wound infection & abscess deemed treatable with oral antibiotics on an outpatient basis
3.Patients with cellulitis, wound infection & abscess who have no signs of systemic toxicity and have no uncontrolled co-morbidities.
4.Written informed consent obtained.
5.16 years of age or older.
6.Fluency in written and spoken English.
7.Willing to return for study follow-up or to have the research nurse or clinical project coordinator visit them.
8.Willing to receive a telephone call from a study investigator.

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Penicillin allergy (self-reported or confirmed).
2.Any cellulitis wound infection & abscess that treating clinicians deem treatable with intravenous (IV) antibiotics.
3.
3.Patients that may have a significant systemic upset such as acute confusion, tachycardia, tachypnoea, hypotension or may have unstable co-morbidities that may interfere with a response to therapy or have a limb threatening infection due to vascular compromise.
4.Patients who may have a severe life threatening infection such as necrotizing fasciitis.
5.Any cellulitis wound infection & abscess of the perineal region.
6.Patients who have received more than 24 hours of effective antibiotics for the current episode of acute cellulitis, wound infection & abscess
7.Any medical condition, based on clinical judgment that may interfere with the interpretation of the primary outcome measures (e.g. a chronic skin condition at the site of the cellulitis wound infection or abscess).
8.Immunodeficiency from primary or secondary causes (e.g. corticosteroids, chemotherapeutic agents).
9.Previous history of renal dysfunction or known chronic kidney disease under the care of a nephrologist. ?
10.Previous history of liver dysfunction defined as chronically deranged liver function tests elicited from the medical notes or history.
11.Suspected or confirmed septic arthritis.
12.Suspected or confirmed osteomyelitis.
13.Infection involving prosthetic material.
14.Pregnant or lactating women.
15.Patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction
16.Patients with a previous history of methicillin-resistant staphylococcus aureus (MRSA) colonisation/infection.
17.Patients with lactose intolerance diagnosed by a medical professional.
18.Patients currently taking probenecid, neomycin, chloramphenicol, erythromycin , tetracyclines sulfinpyrazone, methotrexate, guar gum or an oral anticoagulant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified