E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infection of the skin and subcutaneous tissues (cellulitis) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007882 |
E.1.2 | Term | Cellulitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015145 |
E.1.2 | Term | Erysipelas |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021531 |
E.1.2 | Term | Impetigo |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000269 |
E.1.2 | Term | Abscess |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048038 |
E.1.2 | Term | Wound infection |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016936 |
E.1.2 | Term | Folliculitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017557 |
E.1.2 | Term | Furunculosis |
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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 |
To compare the efficacy, tolerability and safety of oral flucloxacillin and phenoxymethylpenicillin with oral flucloxacillin alone in the treatment of uncomplicated skin and skin structure infections.
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E.2.2 | Secondary objectives of the trial |
To profile,where possible, the bacteriological causes of cellulitis in our catchment population. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
It is intended to carry out a Phase IV, double blinded, placebo controlled, prospective randomised controlled trial comparing the two treatment arms on patients attending the emergency department of Beaumont Hospital Dublin. It is intended to obtain written informed consent from each patient before enrolment. In patient s between the ages of 12 and 16 years of age, it is intended to obtain consent from parent / next of kin.
PATIENTS
Eligible patients will include those aged >12 years of age with uncomplicated skin and / or skin structure infections that can be treated with antibiotics for a period of 7-10 days. These infections may include, but are not limited to, the following clinical descriptors: Cellulitis Erysipelas Impetigo Simple Abscess Wound infection Furunculosis Folliculitis
Inclusion criteria • >12 years of age • Skin infection +/- skin structure infection that is treatable with oral antibiotic • Any 2 of the following signs erythema / warmth / tenderness / swelling / purulent drainage or discharge / regional lymphadenopathy / induration
Women of childbearing potential will be requested to submit a pretrial urinary pregnancy test, and agree to use effective contraception throughout the study.
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E.4 | Principal exclusion criteria |
Exlusion criteria
• Pregnancy • Lactation • Chronic skin condition at the site of infection • Infection involving prosthetic material • Thermal injury • Acne vulgaris • Perirectal abscess / cellulitis (high risk of anaerobic infection) • Fungal infection of scalp or nail bed • Suspected bacteraemia • Infection severe enough to require intravenous antibiotic • Immunodeficiency • Significant vascular disease at the site of infection • Concomitant treatment with oral or parenteral or topical antibiotics at infection site • Hypersensitivity to penicillin • Use of any systemic antibiotic within 7 days • Patients taking systemic corticosteroids at a dose exceeding 15 mg (or equivalent) per day for greater than 7 days
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical cure: Signs and symptoms of infection present at enrolment resolved or improved sufficiently such that further antibiotic therapy is deemed unnecessary
Clinical failure: Persistent or worsening signs and symptoms, or improvement only after additional antibiotic therapy prescribed
Clinical relapse: Initial improvement in signs and symptoms at treatment completion visit followed by worsening or reappearance of signs and symptoms at test of cure visit.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |