ATB therapy in diabetic foot infectio
- Conditions
- Diabetic foot infectionMedDRA version: 20.0Level: LLTClassification code 10004043Term: Bacterial infection in conditions classified elsewhere and of unspecified siteSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-001997-27-CZ
- Lead Sponsor
- Institut klinické a experimentální medicíny
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method