Epidemiology of adverse events and Clostridium difficile-associated diarrhea during long-term antibiotic therapy for osteoarticular infections

Schindler, Maximilian; Bernard, Louis; Belaieff, Wilson; Gamulin, Axel; Racloz, Guillaume; Emonet, Stéphane; Lew, Daniel Pablo; Hoffmeyer, Pierre; Uçkay, İlker

doi:10.1016/j.jinf.2013.07.017

Cited by 33 publications

(28 citation statements)

References 20 publications

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“…The incidence of resistant pathogens reached 15% and the rate of transient renal insufficiency reached 30% in one study [15]. Other author groups reported nausea, drug-induced hepatitis, Clostridium difficile-colitis [17]), and central line-related problems from intravenous therapy [2,15] when treating orthopedic infections, including DFIs.…”

Section: Discussionmentioning

confidence: 94%

Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials

Waibel

Berli

Catanzaro

et al. 2019

Preprint

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Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We will perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is “remission of infection” after a minimal follow-up of two months. The secondary outcomes for both RCT are the incidence of adverse events and the overall treatment costs. The First RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The Second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion: Both parellel RCTs will repond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to assure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4th September 2019. Protocol version: 2 (15th July 2019)

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Section: Discussionmentioning

confidence: 94%

Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials

Waibel

Berli

Catanzaro

et al. 2019

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…The incidence of resistant pathogens reached 15% and the rate of transient renal insufficiency reached 30% in one study [15]. Other author groups reported nausea, drug-induced hepatitis, Clostridium difficile colitis [17], and central line-related problems from intravenous therapy [3,15] when treating orthopedic infections, including DFIs.…”

Section: Discussionmentioning

confidence: 94%

Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials

Waibel

Berli

Catanzaro

et al. 2020

Trials

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Background: Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of postdebridement systemic antibiotic therapy are noninferior (10% margin, 80% power, alpha 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCTs is remission of infection after a minimal follow-up of 2 months. The secondary outcomes for both RCTs are the incidence of adverse events and the overall treatment costs. The first RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 versus 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 versus 4 days for remaining soft tissue infection. The second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 versus 20 days of antibiotic therapy for soft tissue infections; and 3 versus 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion: Both parallel RCTs will respond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to ensure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration: ClinicalTrials.gov, NCT04081792. Registered on 4 September 2019.

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“…The incidence of resistant pathogens reached 15% and the rate of transient renal insufficiency reached 30% in one recent study [15]. Other author groups reported nausea, drug-induced hepatitis, Clostridium difficilecolitis [17]), and central line-related problems from intravenous therapy [2,15] when treating orthopedic infections, including DFIs.…”

Section: Discussionmentioning

confidence: 98%

Study Protocol: Optimization of the surgical and medical management of diabetic foot infections

Waibel¹,

Berli²,

Catanzaro³

et al. 2019

Preprint

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Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI.Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is "remission of infection" after a minimal follow-up of two months. The 1 st RCT allocates the amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The 2 nd RCT randomizes the conservative approach in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, internist and infectiology care.During the surgeries, we collect tissues for BioBanking and future laboratory studies.Discussion: Both parellel RCT will enable to prescribe less antibiotics for DFI; for a conservative therapy and after amputation. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4 th September 2019. Protocol version : 2 (15 th July 2019) Study settingThe Balgrist University Hospital in Zurich is a tertiary referral center for DFI and amputations (emergency and elective consultations with a 24-hour service) and affiliated to the University of Zurich. Regarding DFIs, it resumes a multidisciplinary team composed of four diabetic foot surgeons, three internist physicians, a hospital pharmacist, five specialized wound nurses, musculoskeletal expert radiologists, a diabetes nurse, three nutritionists, a shoemaker, a prosthesis specialist, and up to four infectious diseases physicians who are specialized in orthopedic infections. Moreover, this team is supported by an in-house company for orthopedic footwear (Balgrist Tec) and individual adaptations of off-loading devices, a re-education unit, physical therapy, a research campus (Balgrist

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Epidemiology of adverse events and Clostridium difficile-associated diarrhea during long-term antibiotic therapy for osteoarticular infections

Cited by 33 publications

References 20 publications

Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials

Optimization of the antibiotic management of diabetic foot infections - Protocol for two randomized controlled trials

Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials

Study Protocol: Optimization of the surgical and medical management of diabetic foot infections

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