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NCT Number: NCT02230813

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Connolly Hospital Banchardstown, Dublin, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Treatment failure

    Time frame: 2 weeks post commencement of oral treatment

    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.

Secondary outcomes

  1. Treatment failure - change in type or dose

    Time frame: 2 weeks

    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. Inter-observer reliability for candidate predictor variables

    Time frame: At enrolment

    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.

  3. Loss to follow up

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2014
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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