Atopic Eczema MedDRA version: 14.1 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Flucloxacillin 250mg / 5ml Granules for Suspension
Product Name: Flucloxacillin 250 mg/5ml Granules for Oral Solution
Product Code: J01CF05
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: Children (aged 3 months to less than eight years) with atopic eczema (as defined by UK working party (Appendix I)) who are presenting in primary care, and where their primary care clinician has a clinical suspicion of infected eczema. This could include children where: - The eczema is failing to respond to standard treatment with emollients and / or mild - moderate topical corticosteroids. - There is a flare in the severity or extent of the eczema. - There is weeping or crusting. Are the trial subjects under 18? yes Number of subjects for this age range: 516 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA: Children will not be eligible for inclusion if they have: - Used oral or topical antibiotics within the past week. - Used potent or very potent topical corticosteroids. - Used oral corticosteroids within the past week. - Primary care clinician believes the patient has a severe infection requiring immediate antibiotics or is arranging immediate hospitalisation or urgent (same or next day) dermatology referral because of the severity of the eczema or suspected infection. - Features suggestive of eczema herpeticum (significant pain, punched out lesions). - Current significant congenital or acquired immune suppression sufficient to have clinical consequences. - Known renal and/or hepatic impairment. - Allergy to penicillin and erythromycin or allergy to penicillin and contraindication to erythromycin, such as current use of medication that is known to interact with erythromycin (see the SmPC for Erythromycin). - Allergy to fusidic acid. - Current use of any medication that is known to interact with fusidic acid (see SmPC for Fusidic Acid). Or if they do not have: - A parent or legal guardian who is able to provide written informed consent. - A parent/legal guardian (or a person delegated by the parent/legal guardian) who expects to be available for follow-up visits at 1, 2, and 4 weeks and who understands English well enough to complete simple verbal and written questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the addition of oral or topical antibiotic treatment to treatment with corticosteroid cream, reduce eczema severity in children with suspected infected eczema in primary care?;Timepoint(s) of evaluation of this end point: POEM will be adminstered to participants' parent/carer at baseline and 2 weeks.;Secondary Objective: To assess the short-term (up to four weeks) effectiveness of oral and topical antibiotics on subjective and objective severity, quality of life, impact on family, and daily symptoms. To assess the effectiveness of oral and topical antibiotics on subjective and objective severity, and quality of life at 3 months. To compare oral and topical antibiotic treatments in terms of short and long-term effects, adverse effects, parent preference, and effect on prevalence of colonisation/infection with resistant organisms. To assess the short and long-term cost-effectiveness of treating suspected atopic eczema with oral or topical antibiotics, in terms of cost per unit reduction in subjective outcome severity. To undertake an exploratory cost utility analysis using a new condition-specific preference-based measure of health for children. To describe clinical features associated with infection (defined both microbiologically and in terms of benefit from antimicrobials). To descri;Primary end point(s): The primary outcome will be an assessment of subjective severity at two weeks as measured using the validated Patient-Oriented Eczema Measure (POEM). POEM is based on symptoms over the previous week and therefore will be measuring symptom severity during the week following the end of experimental treatment, the period when a treatment effect is most likely. We have chosen a subjective measure for our primary outcome in recognition of the importance of measuring effects that are of importance to patients. POEM has been shown to be valid and reliable, easy to complete, sensitive to change, and is recommended for use in trials of atopic ecz | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Subjective eczema severity will also be measured using the POEM. - Objective eczema severity will be measured using the Eczema Area and Severity Index (EASI). -Quality of life will be assessed using the Infants Dermatology Quality of Life instrument (IDQoL). -Impact on the family will be measured using the Dermatitis Family Impact (DFI) instrument. The IDQoL is intended for children up to 4 years of age. -A 4 question condition-specific, preference-based measure of health for children will be used for the exploratory cost utility analysis. -A daily diary will be used to record symptom severity, medication use, carers’ preference for treatment (recorded at 2 weeks), and healthcare resource use during the first 4 weeks. The diary will record the following symptoms each day: carer’s assessment of overall severity, itch, sleep disturbance, oozing or weeping, bleeding, fever, and possible adverse effects (nausea, vomiting, diarrhoea, abdominal pain, joint pains, and new rash). -Microbiology analysis of anterior nares, oropharynx and eczamatous skin.;Timepoint(s) of evaluation of this end point: - POEM at 1 week, 4 weeks and 3 months. - EASI at baseline, weeks 2 and 4. - IDQoL/CDLQI at baseline, weeks 2, 4 and 3 months. - DFI at baseline, weeks 2, 4 and 3 months. - Health Utility at baseline, weeks 2, 4 and 3 months. - Medication Use at week 1 and in 4-week-long participant diary. - Parental Preference for treatment at week 1. - Daily symptoms and consultations (NHS Resource Use) and antibiotic use for eczema in 4-week-long participant diary. - Microbiology analysis of anterior nares, oropharynx and eczamatous skin at baseline, week 2, 3 months and 12 months. | — |
Countries
United Kingdom
Contacts
Public ContactTrial Manager
Cardiff University
Outcome results
None listed