E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetic foot infection |
Therapy of diabetic foot infection which require i.v. ATB treatment - pharmacodynamics and pharmacokinetics of ATB usage will be monitored when used ATB under different ATB schemes. Healing of diabetic wounds, progression of infectious complications and possible imúact on intestinal microbiota will be assessed |
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E.1.1.1 | Medical condition in easily understood language |
diabetic foot infection |
infekce u syndromu diabetické nohy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10004043 |
E.1.2 | Term | Bacterial infection in conditions classified elsewhere and of unspecified site |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The aim of our study is to assess the tissue penetration and bactericidal effect of commonly used beta-lactam and cephalosporin ATBs administered at standard doses and at different dosage schemes (boluses vs. continuously) with regards to the state of the arterial and microcirculation systems. The impact of different ATB schemes on the parameters of DF infection and it´s eradication and changes in the intestinal microbiota, selected immune parameters and the intestinal barrier in accordance with different ATB schemes will be also examined. |
As primary endpoints we will assess serum and tissue ATB concentrations applied under different regimens, evaluation of bactericidal activity with regard to various ATB application schemes, the impact of PAD on ATB tissue penetration, detection of faecal microbiota and intestinal barrier changes in connection to different regimens of ATB therapy in DF patients. |
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E.2.2 | Secondary objectives of the trial |
As secondary endpoints we looked for changes in microbial findings, advancement or eradication of infection (clinical and microbiological findings, lab markers, osteomyelitis rates), duration of ongoing ATB therapy, changes in innate and adaptive immunity and surgical procedure rate. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients included into the study should fullfil the following criteria:
- Patients with Type 2 diabetes mellitus and DF infection (DF ulcers of Texas 2-3/B or D) indicated for i.v. ATBs (ceftazidime or amoxicillin/clavulanic acid)
- Positive tissue culture
- Signed Informed consent
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E.4 | Principal exclusion criteria |
Patients who fullfilled one of these criteria will be excluded:
Severe hepatic insufficiency, chronic renal insufficiency/failure – stage 4-5 based on the Chronic Kidney Disease (CKD) classification, severe malnutrition, indication for emergent foot amputation, recent percutaneous transluminal angioplasty (within 2 weeks), indication for acute revascularisation with regard to rapid progression of PAD or acute arterial ischaemia, allergy to test ATBs, presence of a diagnosed neoplasm, pregnancy, lactation, septic shock, active Ebstein-Barr virus, Inflammatory Bowel Disease (IBD), coeliac disease or any other malabsorption disease, acute gastroenteritis.
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E.5 End points |
E.5.1 | Primary end point(s) |
The subject will be excluded if serious adverse develop
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Discontinuation of the treatment for case of adverse events |
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E.5.2 | Secondary end point(s) |
non-compliace with regularly study visits or unexpected serious adverse event |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | 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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |