| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 7.1 | | E.1.2 | Level | PT | | E.1.2 | Classification code | 10021531 | |
| 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 and safety of topical applications of 1% SB-275833 ointment given for 5 days with topical 2% sodium fusidate ointment given for 7 days, in the treatment of impetigo in adult and paediatric subjects. | |
| E.2.2 | Secondary objectives of the trial | |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | A subject will be eligible for inclusion in this study only if all of the following criteria apply:
1.The subject is greater than or equal to 9 months of age.
2.The subject has a clinical diagnosis of primary impetigo (bullous and non-bullous) defined as follows:
A lesion or a group of lesions characterised by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-coloured crusts surrounded by an erythematous margin.
3.The subject has no more than 10 discrete localised impetigo lesions suitable for topical treatment.
4.The infected lesion(s) should not exceed 100 cm2 in area with surrounding erythema not extending more than 2 cm from the edge of any lesion or up to a maximum of 2% body surface area for subjects < 18 years of age. If a subject has multiple lesions the total area should not exceed a total of 100 cm2 in area.
5.Female subjects of child-bearing potential have had a negative urine pregnancy test prior to enrolment.
6.The subject has a Skin Infection Rating Scale Score of at least 8
7.The subject is willing and able to comply with the study protocol.
8.The subject has given written informed, dated consent to participate in the study.
For paediatric subjects under the legal age of consent (dependent on local country practice):
9.The parent/legal guardian is willing to comply with the protocol.
10.The child has given their assent to participate in the study. (This is only required if the child is of an age to assent to enroll in the study; age of assent to be determined by IRB/IEC, or to be consistent with local legal requirements).
11.The parent/legal guardian has given written, informed, dated consent for the subject to participate in the study.
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| E.4 | Principal exclusion criteria | A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.The subject has demonstrated a previous hypersensitivity reaction to sodium fusidate or to any component of the ointment (refer to the prescribing information for composition of the sodium fusidate ointment), or the subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of SB-275833 ointment).
2.The subject has an underlying skin disease (e.g., pre-existing eczematous dermatitis) or skin trauma, with clinical evidence of secondary infection.
3.The subject has signs and symptoms of systemic infection (such as fever, defined as an oral temperature greater than 101° F or 38.3° C).
4.The subject has a bacterial skin infection which, due to depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic. Examples include extensive cellulitis, furunculosis and abscess.
5.The subject has received a systemic antibacterial, steroid, or has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials and antifungals) directly to the impetigo lesion(s), less than 24 hours prior to study entry.
6.The subject has a serious underlying disease that could be imminently life threatening.
7.The subject is pregnant, breast-feeding or planning a pregnancy during the study.
8.The subject has used an investigational drug within 30 days prior to entering the study.
9.The subject has been previously enrolled in this study or in any other study involving SB-275833.
During the study period, the infected lesion(s) may only be treated with the topical agent to which the subject was randomised, i.e. 1% SB-275833 ointment or 2% sodium fusidate ointment.
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| E.5 End points |
| E.5.1 | Primary end point(s) | •Clinical response (clinical success or clinical failure) to study medication at end of therapy, two days after treatment (Day 7 for 1% SB-275833 ointment and Day 9 for 2% sodium fusidate ointment)
The hypothesis to be tested by the primary endpoint is that the clinical efficacy of 1% SB-275833 ointment at end of therapy is non-inferior to that of 2% sodium fusidate ointment in the treatment of subjects with impetigo
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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 | 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 | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| 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 | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| 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 | Yes |
| E.8.1.4 | Double blind | No |
| 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 | No |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
