ATB therapy in diabetic foot infection

Rationalisation of ATB therapy in diabetic foot infection and its impact on the intestinal microbiota - DFIATIM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001997-27-CZ

Enrollment

Registered

2019-06-04

Start date

2020-07-17

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic foot infection MedDRA version: 20.0 Level: LLT Classification code 10004043 Term: Bacterial infection in conditions classified elsewhere and of unspecified site System Organ Class: 100000004862

Interventions

Trade Name: Fortum 2g Product Name: ceftazidime Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: CEFTAZIDIME CAS Number: 72558-82-8 Concentration unit: g gram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: 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.;Primary end point(s): The subject will be excluded if serious adverse develop ;Timepoint(s) of evaluation of this end point: Discontinuation of the treatment for case of adverse events	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: 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.;Primary end point(s): The subject will be excluded if serious adverse develop ;Timepoint(s) of evaluation of this end point: Discontinuation of the treatment for case of adverse events

—

Secondary

Measure	Time frame
Secondary end point(s): non-compliace with regularly study visits or unexpected serious adverse event;Timepoint(s) of evaluation of this end point: 14 days	—

Countries

Czech Republic

Contacts

Public ContactVladimíra Fejfarová

Institut klinické a experimentální medicíny

vlfe@ikem.cz00420603877381

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026