The CREAM Study - Children with Eczema Antibiotic Management Study

Phase 1

• Conditions: Atopic Eczema; MedDRA version: 14.1 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003591-37-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-27
• Study Completion: 2015-03-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 113

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: 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified