E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondarily-infected traumatic lesions |
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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 | 10040872 |
E.1.2 | Term | Skin infection |
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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 determine the most effective dose of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of 3 different doses of GF-001001-00 cream for treatment of adult patients with secondarily infected traumatic lesions |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males and females ≥18 years of age. • Presence of small laceration, sutured wound, abrasion or burn, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should be comprised between 2 and 10 cm in length or a total surface area of 2-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of the wound. Abrasions and burns should not exceed a total surface area of 100 cm2 with surrounding erythema not extending more than 2 cm from the edge of the abrasion. • The infection is accompanied by pus/exudate and one or more of the following local signs and symptoms: - Pain - Erythema / Inflammation - Tissue warmth - Tissue oedema - Crusting - Itching • Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 2. • An accessible infection site for culture. • Females of childbearing potential must use a reliable method of contraception (i.e. barrier type devices [e.g. female condom, diaphragm, contraceptive sponge] only in combination with a spermicide; intra-uterine devices; oral, injectable, transdermal or implantable contraceptives only in combination with a barrier method). Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least one year prior to screening), or surgically sterile (tubal ligation and/or hysterectomy). • Willing and able to give informed consent. |
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E.4 | Principal exclusion criteria |
• Bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic (e.g. cellulitis, abscess, ulcer). • A complicated skin and skin structure infection as judged by the investigator. • Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; a long-acting injectable antibiotic within 30 days. • Application of any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion within 24 hours prior to study entry. • Any infection which requires the use of a concomitant antimicrobial agent in addition to study drug. • A chronic or underlying skin condition at the site of infection (e.g. a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g. catheter tunnel infections, orthopaedic hardware). • A wound secondary to animal or human bite • Any infection site that requires intraoperative surgical debridement or excision of the infected area. • Documented or suspected bacteraemia. • Daily dose of >15 mg of systemic prednisone or equivalent for >10 days within the period starting 14 days prior to study drug administration or anticipated through the study period. • Known human immunodeficiency virus (HIV) infection, or evidence of clinically significant immunosuppression. • Pregnancy or lactation • Hypersensitivity to quinolones. • Receipt of an investigational agent ≤3 months prior to the baseline evaluation. • Underlying condition and/or disease that, according to the judgment of the Investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up. • Previous enrolment in this protocol. • Known or suspected hypersensitivity to the investigational product or any of the excipients in the cream. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint:
• Clinical response (success or failure) at the Final Visit (Day 14) in the ITTC population.
Safety endpoints:
• Adverse events. • Clinical laboratory parameters (haematology, clinical chemistry, urinalysis). • Vital signs (oral temperature, respiratory rate, pulse rate, BP). • Physical examination. • Exposure to treatment and treatment compliance.
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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 | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | No |
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
| 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |