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

NCT ID: NCT02230813

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-27

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abel Wakai, MD FRCS FCEM

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons, Ireland

Locations

Connolly Hospital Banchardstown

Dublin, , Ireland

Emergency Department Beaumont Hospital

Dublin, , Ireland

Mater Misericoridiae University Hospital

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 32868346 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26112223 (View on PubMed)

Other Identifiers

14/53

Identifier Type: -

Identifier Source: org_study_id