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"
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Diabetic foot
(BASEC)
Age of majority Diabetic foot disease Osteomyelitis (bone infection) (BASEC)
Ausschlusskriterien
An amputation has already been performed Removal of osteosynthesis material Already in antibiotic treatment (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Prof. Dr.med. Ilker Uckay Universitätsklinik Balgrist
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Felix Waibel
044 386 57 59
felix.waibel@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Allgemeine Auskünfte
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Wissenschaftliche Auskünfte
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
03.09.2019
(BASEC)
ICTRP Studien-ID
NCT04081792 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
“Optimization of the surgical and medical management of diabetic foot infections” (BASEC)
Wissenschaftlicher Titel
Optimization of the Surgical and Medical Management of Diabetic Foot Infections (ICTRP)
Öffentlicher Titel
Optimal Antibiotics for Operated Diabetic Foot Infections (ICTRP)
Untersuchte Krankheit(en)
Diabetic Foot Infection;Surgical Wound;Antibiotic Side Effect;Infection (ICTRP)
Untersuchte Intervention
Procedure: Antibiotic therapy (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
DFI_Cohort (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04081792 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar