Children with eczema, antibiotic management study

• Register: ISRCTN
• Last refreshed on: 26 August 2019
• Main ID: ISRCTN96705420
• Date of registration: 27/06/2012
• Prospective Registration: Yes
• Primary sponsor: Cardiff University (UK)
• Public title: Children with eczema, antibiotic management study
• Scientific title: The CREAM Study:? ChildRen with Eczema, Antibiotic Management Study: a randomised controlled trial
• Date of first enrolment: 01/09/2012
• Target sample size: 510
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN96705420
• Study type: Interventional
• Study design: Three-arm randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Nick Francis

Key inclusion & exclusion criteria

Inclusion criteria:
Children (aged 3 months to less than five years) with atopic eczema (as defined by UK working party criteria) who are presenting in primary care and their treating clinician suspects infected eczema because of at least one of the following:
The UK working party criteria state that in order to qualify as a case of atopic eczema with the UK diagnostic criteria, the child MUST have:
1. An itch skin condition in the last 12 months
2. And three or more of the following:
2.1. Onset below age 2 (Not used in children under 4 years old)
2.2.History of flexural involvement.
2.3. History of general dry skin atopic disease (In children aged under 4 years old, history of atopic disease in a first degree relative may be included)
2.4. Personal history of other atopic disease
3. The eczema is failing to respond to standard treatment
4. There is a flare in the severity or extent of the eczema
5. There is weeping, crusting, or pustules

Exclusion criteria:
1. Use of oral or topical antibiotics in the past week
2. Use of potent (Betamethasone valerate 0.1%, Betacap, Betesil, Bettamousse, Betnovate, Cutivate, Diprosone, Elocon, Hydrocortisone butyrate, Locoid, Locoid Crelo, Metosyn, Nerisone, Synalar, Aureocort, Betnovate-C, Betnovate-N, Fucibet, Lotriderm, Synalar C, Synalar N, Diprosalic) or very potent (Clarelux, Dermovate, Etrivex, Nerisone Forte, Dermovate-NN) corticosteroids within the past week
3. Immune suppression
4. Features suggestive of eczema herpeticum (significant pain, punched out lesions)
5. Severe infection (systemic upset, cellulitis) ) and/or suspected infection warrants immediate hospitalisation or urgent dermatology referral
6. Severity of eczema
7. Known renal and / or hepatic impairment
8. 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
9. Allergy the fusidic acid
10. Current use of any medication that is known to interact with fuscidic acid
11. Extensive eczema (EASI score ? 40 [equates to moderately severe eczema affecting 80% of body surface area])


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Infected eczema
Skin and Connective Tissue Diseases
Atopic dermatitis

Intervention(s)

The active medications being evaluated in this trial are well established and already widely used within their licensed indications. The active medications will not be used outside their licensed indication in the course of this trial. This is a study of their added value.

The trial has three treatment arms. Participants in all three treatment arms will receive a suitable standard topical corticosteroid treatment for their eczema and comprehensive verbal and written eczema care instructions. All participants will also receive additional monitoring and support of a trained research nurse.

Group 1: Oral antibiotic flucloxacillin (or erythromycin if penicillin allergic) and topical placebo.
Group 2: Oral placebo and topical antibiotic fusidic acid 2% cream.
Group 3: Oral placebo and topical placebo

Groups 1, 2 and 3:
All patients will be prescribed topical steroid cream [topical Eumovate cream (for eczema on trunk and/or limbs) and/or topical hydrocortisone 1% cream (for eczema on face)] by their GP.

Primary Outcome(s)

Assessment of subjective severity at two weeks as measured using the validated Patient-Oriented Eczema Measure (POEM). The 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. The POEM has been found to be valid and reliable, easy to complete, sensitive to change, and was one of three outcome measures recommended in a recent systematic review of outcome measures for atopic eczema (AE).

Secondary Outcome(s)

1. Subjective eczema severity will be measured using the Eczema Area and Severity Index (EASI).This was also recommended as an eczema outcome measure, and was selected over SCORAD because it includes assessments of each of four body areas and therefore may be of value in assessing response within the infected region. In addition, the SCORAD combines subjective and objective assessments.
2. Quality of life will be assessed using the Infants Dermatology Quality of Life instrument (IDQoL)
3. Impact on the family will me measured using the Dermatitis Family Impact (DFI) instrument.
These are both well-validated, short, easy to use instruments, and we have expertise in our team in using them. The IDQoL is intended for children up to 4 years of age. However, it has been successfulLY used in studies with children up to 5.
4. A four question condition-specific, preference-based measure of health for children will be used for the exploratory cost utility analysis.
5. A daily diary will be used to record symptom severity, medication use, carers? preference for treatment (recorded at 2 weeks), and healthcare use during the first 4 weeks. The diary will record the following symptoms each day: carers assessment of overall severity, itch, sleep disturbance, oozing or weeping, bleeding, fever, and possible adverse effects (nausea, vomiting, diarrhoea, abdominal pain, joint pains, new rash). We will pilot this diary with a sample of carers prior to use in the trial. We have had success in using daily symptom diaries in a number of studies, including four-week diaries, and diaries completed by parents/carers. One study successfully collected daily diary data from the majority of parents/carers for eight weeks. There is also evidence for the reliability and validity of diary data recorded by parents/carers.

Secondary ID(s)

HTA 09/118/03, v1.1

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

REC for Wales Ref:12/WA/0180

Results

• Results available: Yes
• Date Completed: 25/03/2015