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

NCT02230813 | Completed

• 1 other identifier: 14/53
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cellulitis

Keywords

Cohort Study,; Cellulitis,; Skin and Soft Tissue Infection,; Emergency Department,; Clinical Prediction Rule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Treatment failure - change in type or dose

  2 weeks

• Inter-observer reliability for candidate predictor variables

  At enrolment

• Loss to follow up

  2 weeks

Study Arms (1)

Oral antibiotic therapy

Consecutive adult patients attending the study Emergency Departments with cellulitis will be considered eligible for recruitment to the study. Only those patients deemed suitable for oral antibiotic therapy and planned for discharge will be recruited to the study. Oral antibiotic therapy prescribed will be dependent on local institutional prescribing guidelines. For the purposes of the sites enrolling participants, the antibiotic of choice is oral flucloxacillin 500 milligrams four times daily for seven days. We will be assessing the treatment failure rate for this cohort of patients; namely, the number of patients requiring the primary outcome (change from oral to intravenous antibiotic therapy). We will also assess this group of patient for the secondary outcomes listed above.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged \>16 years attending the ED with cellulitis as the primary diagnosis will be consecutively recruited. Only patients who are deemed suitable for an oral antibiotic will be enrolled. Patients who require IV therapy will not be enrolled. Cellulitis may arise de novo, or from a recognised cause such as a wound or ulcer. In order to generate an externally valid clinical prediction rule, we will include all patients attending the ED with cellulitis, including those who may have already been commenced on oral antibiotics (for example, by their general practitioner).

You may qualify if:

• 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:
• Increased warmth over affected area
• Swelling of affected area
• Pain over affected area
• Regional lymphadenopathy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (3)

Connolly Hospital Banchardstown

Dublin, Ireland

Location

Emergency Department Beaumont Hospital

Dublin, Ireland

Location

Mater Misericoridiae University Hospital

Dublin, Ireland

Location

Related Publications (2)

• Quirke M, Mitchell N, Varley J, Kelly S, Boland F, Moughty A, McKeever J, Fahey T, Wakai A. Prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department patients with acute bacterial skin and skin structure infections: a pilot, prospective cohort study. BMJ Open. 2020 Aug 30;10(8):e034057. doi: 10.1136/bmjopen-2019-034057.

  PMID: 32868346 DERIVED

• Quirke M, Boland F, Fahey T, O'Sullivan R, Hill A, Stiell I, Wakai A. Prevalence and predictors of initial oral antibiotic treatment failure in adult emergency department patients with cellulitis: a pilot study. BMJ Open. 2015 Jun 25;5(6):e008150. doi: 10.1136/bmjopen-2015-008150.

  PMID: 26112223 DERIVED

MeSH Terms

Conditions

Cellulitis; Soft Tissue Infections; Emergencies

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Abel Wakai, MD FRCS FCEM

  Royal College of Surgeons, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: March 1, 2015
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

IE (3)