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 | 12.0 |
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) |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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
| |
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 | |
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 |