EUCTR2019-001997-27-CZActive, not recruitingPhase 1
Rationalisation of ATB therapy in diabetic foot infection and its impact on the intestinal microbiota - DFIATIM
Institut klinické a experimentální medicíny0 sites60 target enrollmentStarted: June 4, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
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.
Investigators
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