Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis

Cellulitis Clinical Trial

Official title:

Prevalence and Predictors of Initial Oral Antibiotic Treatment Failure in Adult Emergency Department Patients With Cellulitis: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230813
• Other study ID #: 14/53
• Status: Completed
• Phase: N/A
• First received: August 29, 2014
• Last updated: January 25, 2017
• Start date: March 2015
• Est. completion date: September 27, 2016

Study information

• Verified date: January 2017
• Source: Royal College of Surgeons, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The term cellulitis is a medical term describing a bacterial infection of the skin and tissues beneath the skin. Although it is usually easily treated with antibiotics given either orally or through a vein (intravenously), knowing which route of antibiotic treatment to prescribe to a person attending an Emergency Department with cellulitis is not clear.

A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which patients require oral and which patients require intravenous antibiotics for cellulitis from their first visit to an emergency department. The aim of this is to provide safer care by reducing the risk of a patient returning to the hospital with a worsening infection. It will also promote more cost-effective care by reducing hospital re-attendance rates and wasted antibiotics.

Patients attending the department with cellulitis who are suitable for oral antibiotic treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of study participants in order to reduce bias. A set of physical signs and symptoms will be recorded from each patient in order to determine which ones are associated with them "failing" prescribed oral treatment. A study investigator will then phone the patient after 14 days to see whether they are better or whether they required intravenous antibiotics to get better.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 27, 2016
• Est. primary completion date: September 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age >16 years

• Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable alternative for penicillin allergic patients as listed in the local prescribing guidelines.

• Appearance of typical, plaque-like area of erythema over any body part excluding the perineum within the preceding 5 days with any 2 of the following signs:

• 1.Increased warmth over affected area

• 2.Swelling of affected area

• 3.Pain over affected area

• 4.Regional lymphadenopathy

Exclusion Criteria:

• Requirement for IV antibiotics as decided by the treating clinician.

• Age less than 16 years.

• No telephone or access to a telephone.

• Abscess alone without co-existing signs of cellulitis

• Mammalian bite wounds.

• Infected diabetic foot ulcer

• Necrotising soft tissue infections.

• Perineal cellulitis.

• Suspected septic arthritis or osteomyelitis.

• Decubitus ulcers.

• Bilateral cellulitis (as this entity rarely exists).

• Acute lipodermatosclerosis.

• Acute dermatitis.

• Venous stasis dermatitis.

• Deep vein thrombosis.

• Pregnancy.

• Cognitive impairment.

• Any patient who through language barrier or diminished capacity is unable to understand the scope of the study

Related Conditions & MeSH terms

• Cellulitis
• Emergencies

Locations

Country	Name	City	State
Ireland	Emergency Department Beaumont Hospital	Dublin
Ireland	Mater Misericoridiae University Hospital	Dublin
Ireland	Connolly Hospital Banchardstown	Dublin 15

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	The primary outcome is the proportion of patients initially commenced on oral antibiotics who subsequently require IV antibiotics to achieve treatment response. This will be assessed by means of telephone follow-up performed at 14 days post enrolment into the study. Treatment failure is defined as attendance at a treating Emergency Department for intravenous antibiotic therapy if already commenced on oral therapy.	2 weeks post commencement of oral treatment
Secondary	Treatment failure - change in type or dose	Treatment failure measured by change in prescribed oral antibiotic to another oral antibiotic.; Treatment failure measured by change in prescribed dose of oral antibiotic to a higher dose of the same antibiotic	2 weeks
Secondary	Inter-observer reliability for candidate predictor variables	Assessment of inter-observer reliability for the candidate predictor variables listed. This will be performed in at least 10% of patients enrolled into the study by a second recruiting clinician.	At enrolment
Secondary	Loss to follow up	Assessment of the loss to follow-up rate and usefulness of the data collection proforma in the pilot study will also prove valuable for planning for the live study.	2 weeks