Duration of antibiotic administration after amputation in case of possible residual infection in diabetic foot "Duration of antibiotic administration after amputation in case of possible residual infection in diabetic foot"
Summary description of the study
Nowadays, the duration of antibiotic therapy is based on global experience. However, antibiotics are not without complications. The infectiology of recent years focuses on shortening the duration of antibiotics to contain the pandemic of antibiotic resistance. In the field of diabetic foot infections, it is highly likely that antibiotic consumption can be reduced by half, with a corresponding reduction in costs, side effects, and length of hospital stay.
(BASEC)
Intervention under investigation
We reduce the duration of antibiotic therapy through two different prospective studies that complement each other. In a first (prospective), randomized (participating patients are assigned to different groups by random mechanism) study, we want to investigate the duration of antibiotic administration if a residual infection is present after prior amputation. For still infected soft tissues, patients receive, depending on allocation, between 1 and 4 days of oral or intravenous (into the vein) antibiotics. In case of residual infection in the bone, patients receive, depending on allocation, between 1 and 3 weeks of oral or intravenous (into the vein) antibiotics.
In the second study with other patients with diabetic foot infections (who were not amputated), we investigate the respective duration between 10 and 20 days of antibiotics for pure soft tissue infections in the foot, and between 3 and 6 weeks of targeted antibiotic therapy for bone infection.
In a prospective (forward-looking), randomized (participating patients are assigned to different groups by random mechanism) study, we compare infection-free status after an antibiotic therapy duration of 10 versus 20 days (for patients with pure soft tissue infection) or 3 versus 6 weeks (for patients in whom osteomyelitis (= a bone infection) is treated without removal of the bone). Only antibiotics that are approved by Swissmedic and commonly available on the Swiss market are used. The type of antibiotic depends on the (presumably) underlying bacterium of the infection.
(BASEC)
Disease under investigation
Diabetic foot
(BASEC)
Age of majority Diabetic foot disease Osteomyelitis (bone infection) (BASEC)
Exclusion criteria
An amputation has already been performed Removal of osteosynthesis material Already in antibiotic treatment (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Prof. Dr.med. Ilker Uckay Universitätsklinik Balgrist
(BASEC)
Contact
Contact Person Switzerland
Felix Waibel
044 386 57 59
felix.waibel@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
General Information
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Scientific Information
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
03.09.2019
(BASEC)
ICTRP Trial ID
NCT04081792 (ICTRP)
Official title (approved by ethics committee)
“Optimization of the surgical and medical management of diabetic foot infections” (BASEC)
Academic title
Optimization of the Surgical and Medical Management of Diabetic Foot Infections (ICTRP)
Public title
Optimal Antibiotics for Operated Diabetic Foot Infections (ICTRP)
Disease under investigation
Diabetic Foot Infection;Surgical Wound;Antibiotic Side Effect;Infection (ICTRP)
Intervention under investigation
Procedure: Antibiotic therapy (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: 99 Years
Minimum age: 18 Years
Inclusion Criteria:
- Age = 18 years
- Diabetic foot infections or ischemia/necrosis with surgical
amputation/disarticulation level in vicinity of MRI signs of infection
- At least two months of follow-up from hospitalization
- Patient signing to participate, including acceptance of local wound care,
-off-loading and arterial re-vascularization (if clinically indicated).
Exclusion Criteria:
- At least 5 cm of distance between amputation level and infection.
- Any concomitant infection requiring more than 5 days of systemic antibiotic therapy
- Eventual osteosynthesis material not removed (ICTRP)
not available
Primary and secondary end points
Number of Participants with a clinical and microbiological remission of treated infection at 2 months (ICTRP)
Anatomical Amputation Level Determination by MRI;Rates of adverse events of antibiotic therapy;Duration of wound healing time;Numbers of Cost and resource reductions;Scales of Patient's satisfaction;Statistical evaluation of risk factors for failure of remission (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Ilker U?kay, PD MD;Ilker Uckay, PD MD;Ilker U?kay, PD, MD, ilker.uckay@balgrist.ch, +41443863705;+41 44 386 37 05, Balgrist University Hospital, Zurich, Switzerland, (ICTRP)
Secondary trial IDs
DFI_Cohort (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04081792 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available