| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
| Eczema is a condition that causes the skin to become itchy, red, dry and cracked. It is a long-term, or chronic, condition. Atopic eczema, also known as atopic dermatitis. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003641 |
| E.1.2 | Term | Atopic eczema |
| E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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? |
|
| E.2.2 | Secondary objectives of the trial |
| 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 |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | 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 eczema. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| POEM will be adminstered to participants' parent/carer at baseline and 2 weeks. |
|
| E.5.2 | 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. |
|
| E.5.2.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Yes |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | Yes |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 3 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 93 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| LVLS - This represents the last participant consented and randomised to receive IMP, who completes all the data collection time points as stated in the protocol, including the microbiology swabs at the 12 month follow-up. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 3 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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