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"
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'investigation
Diabetic foot
(BASEC)
Age of majority Diabetic foot disease Osteomyelitis (bone infection) (BASEC)
Critères d'exclusion
An amputation has already been performed Removal of osteosynthesis material Already in antibiotic treatment (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Prof. Dr.med. Ilker Uckay Universitätsklinik Balgrist
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Felix Waibel
044 386 57 59
felix.waibel@clutterbalgrist.chUniversitätsklinik Balgrist
(BASEC)
Informations générales
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Informations scientifiques
Balgrist University Hospital, Zurich, Switzerland,
+41443863705;+41 44 386 37 05
felix.waibel@clutterbalgrist.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
03.09.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT04081792 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
“Optimization of the surgical and medical management of diabetic foot infections” (BASEC)
Titre académique
Optimization of the Surgical and Medical Management of Diabetic Foot Infections (ICTRP)
Titre public
Optimal Antibiotics for Operated Diabetic Foot Infections (ICTRP)
Maladie en cours d'investigation
Diabetic Foot Infection;Surgical Wound;Antibiotic Side Effect;Infection (ICTRP)
Intervention étudiée
Procedure: Antibiotic therapy (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
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 secondaires
DFI_Cohort (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT04081792 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible