E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cellulitis of the lower leg of adult patients that have been admitted to Landspitali University Hospital and are on iv antibiotics. |
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MedDRA Classification |
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 |
Is to test a new intervention against cellulitis. |
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E.2.2 | Secondary objectives of the trial |
To observe if there are any complications of the new treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. patient with cellulitis of class II in the Eron/Dall classification system for cellulitis 2. patient on iv antibiotics 3. patient who gets admitted to one of the general medicine wards 4. patient who writes and understands icelandic 5. patient who can give written and informed concent to participate in the clinical trial 6. patient admitted for at least six days or for the length of the treatment period 7. patient with no history of any allergies 8. patient who has not used any antibiotic, inflammatory or steroid cream on the diseased leg one day prior admission |
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E.4 | Principal exclusion criteria |
1. childbearing or lactating women 2. patient with HIV, hepatitis or canser 3. patient with COPD or has FEV1<80% or is taking inhalants 4. patient with impared kidney function or has GFR<60ml/min 5. patient with impaired memory, delerium or dementia 6. patient with psoriasis or stasis dermatitis
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E.5 End points |
E.5.1 | Primary end point(s) |
1. patient has finished five days of treatment with oil application to the leg and has finished all outcome measurements on day six and gotten some information/education from the researcher.
The patient drops out of the clinical trial if: 1. patient is discharged to early 2. patient is discharged to a surgical department 3. patient gets any complication or adverse effects because of the new treatment 4. patient dies 5. patient desides to quit participating in the clinical trial 6. patient gets new diagnosis of diseases or any new symptoms |
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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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | 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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The trial ends when about 30 patients have undergone the trial, finished treatment (reaserch or control treatment) and finished every outcome measurement. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |