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"
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Diabetic foot
(BASEC)
Age of majority Diabetic foot disease Osteomyelitis (bone infection) (BASEC)
Criteri di esclusione
An amputation has already been performed Removal of osteosynthesis material Already in antibiotic treatment (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Prof. Dr.med. Ilker Uckay Universitätsklinik Balgrist
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Felix Waibel
044 386 57 59
felix.waibel@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Informazioni generali
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Informazioni scientifiche
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
03.09.2019
(BASEC)
ID di studio ICTRP
NCT04081792 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
“Optimization of the surgical and medical management of diabetic foot infections” (BASEC)
Titolo accademico
Optimization of the Surgical and Medical Management of Diabetic Foot Infections (ICTRP)
Titolo pubblico
Optimal Antibiotics for Operated Diabetic Foot Infections (ICTRP)
Malattie studiate
Diabetic Foot Infection;Surgical Wound;Antibiotic Side Effect;Infection (ICTRP)
Intervento studiato
Procedure: Antibiotic therapy (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
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)
ID secondari
DFI_Cohort (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT04081792 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile