GP information

The study will be performed at the participant’s home or suitable location, as determined by discussion between the research nurse and participant’s parent/carer(s). General Practitioners (GPs) will be considered as a site for the purpose of the trial, and will be under the responsibility of the Principal Investigator (PI) for their region. A GP at each Practice will also be registered as the PI for that practice. Dermatology clinics will also act as sites under the responsibility of the PI for the hospital. General practices and dermatology clinics will refer eligible patients to the research nurse in their region or based in the hospital.

All sites, research nurses, pharmacy sites and research centres will be provided training on study procedures and protocols. Consent, registration and assessments of patients will be the responsibility of the research nurse and coordinated by their research centres (Cardiff, Dundee, Bristol) and the Trial Manager. The overall responsibility for the study will rest with the Co-chief Investigators, Dr Nick Francis and Prof Frank Sullivan. The Trial Manager will act on behalf of the Co-chief Investigators to ensure the smooth and efficient running of all aspects of the study.

General practices will act as sites. The research centres (Cardiff and Bristol) will each recruit approximately 30 general practices in their respective regions (Wales and South West England), with the option of approaching additional practices and/or neighbouring networks if necessary. The procedure for recruiting general practices may vary between the three centres. Practices will either be contacted directly by the local study team or through a local research network. Surgeries that express an interest in the study will be sent written information about the study, which will be followed up by telephone conversations and/or a visit to the surgery.

Practices agreeing to participate will be sent a ‘GP Pack’, which will contain documentation required to become a CREAM Study Site, including a study agreement and the documents required for referring patients and prescribing treatments.

Dermatology clinics will act as sites. Dermatologists or Dermatology Nurses that express an interest in the study will be sent written information about the study, which will be followed up by telephone conversations and/or a visit to the clinic.

Clinics agreeing to participate will be sent a ‘Dermatology Pack’, which will contain documentation required to become a CREAM Study Site, including a study agreement and the documents required for referring patients and prescribing treatments.

If you are GP or a Practice Nurse at a Practice in South Wales or South West England (Bristol), or a Dermatologist or Specialist Nurse from any region:

Please Click Here to Register Your Interest!

Inclusion and Exclusion Criteria

Children are eligible to join the trial if they meet the following inclusion criteria and do not meet any of the exclusion criteria. All queries about patient eligibility should be directed to the CREAM Trial Manager before randomisation (administration of study medication).

Inclusion criteria

Children (aged 3 months to less than eight years) with atopic eczema (as defined by UK working party) who are presenting with 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.

Exclusion criteria

Children will not be eligible for inclusion if they have:
  • Used oral or topical antibiotics to treat a skin infection within the past week.
  • Used potent or very potent topical corticosteroids within the past two days.
  • Used oral corticosteroids within the past week.
  • Treating 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).
  • Known significant comorbid illness (e.g. significant immune compromise)
  • Allergy to fusidic acid or both penicillin and erythromycin.
  • Contraindication to any study medication (penicillin, erythromycin, 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.