EUCTR2016-001528-69-IE
Active, not recruiting
Phase 1
PENICILLIN FOR THE EMERGENCY DEPARTMENT-DIRECTED OUTPATIENT TREATMENT OF CELLULITIS (PEDOCELL) STUDY: A NON-INFERIORITY ADAPTIVE RANDOMISED CONTROLLED TRIAL.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Skin Infection
- Sponsor
- Royal College of Surgeons in Ireland
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Clinically diagnosed cellulitis, wound infection \& abscess affecting any body part, excluding the perineum, and having any two of the following signs:
- •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.
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\.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.
Outcomes
Primary Outcomes
Not specified
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