PMID- 33242083
OWN - NLM
STAT- MEDLINE
DCOM- 20211020
LR  - 20211020
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 73
IP  - 7
DP  - 2021 Oct 5
TI  - Three Weeks Versus Six Weeks of Antibiotic Therapy for Diabetic Foot 
      Osteomyelitis: A Prospective, Randomized, Noninferiority Pilot Trial.
PG  - e1539-e1545
LID - 10.1093/cid/ciaa1758 [doi]
AB  - BACKGROUND: In patients with diabetic foot osteomyelitis (DFO) who underwent 
      surgical debridement, we investigated whether a short (3 weeks) duration compared 
      with a long (6 weeks) duration of systemic antibiotic treatment is associated 
      with noninferior results for clinical remission and adverse events (AEs). 
      METHODS: In this prospective, randomized, noninferiority pilot trial, we 
      randomized (allocation 1:1) patients with DFO after surgical debridement to 
      either a 3-week or a 6-week course of antibiotic therapy. The minimal duration of 
      follow-up after the end of therapy was 2 months. We compared outcomes using Cox 
      regression and noninferiority analyses (25% margin, power 80%). RESULTS: Among 93 
      enrolled patients (18% females; median age 65 years), 44 were randomized to the 
      3-week arm and 49 to the 6-week arm. The median number of surgical debridements 
      was 1 (range, 0-2 interventions). In the intention-to-treat (ITT) population, 
      remission occurred in 37 (84%) of the patients in the 3-week arm compared with 36 
      (73%) in the 6-week arm (P = .21). The number of AEs was similar in the 2 study 
      arms (17/44 vs 16/49; P = .51), as were the remission incidences in the 
      per-protocol (PP) population (33/39 vs 32/43; P = .26). In multivariate analysis, 
      treatment with the shorter antibiotic course was not significantly associated 
      with remission (ITT population: hazard ratio [HR], 1.1 [95% confidence interval 
      CI, .6-1.7]; PP population: HR, 0.8 [95% CI: .5-1.4]). CONCLUSIONS: In this 
      randomized controlled pilot trial, a postdebridement systemic antibiotic therapy 
      course for DFO of 3 weeks gave similar (and statistically noninferior) incidences 
      of remission and AE to a course of 6 weeks. CLINICAL TRIALS REGISTRATION: 
      NCT03615807; BASEC 2016-01008 (Switzerland).
CI  - (c) The Author(s) 2020. Published by Oxford University Press for the Infectious 
      Diseases Society of America. All rights reserved. For permissions, e-mail: 
      journals.permissions@oup.com.
FAU - Gariani, Karim
AU  - Gariani K
AD  - Service of Endocrinology, Diabetes, Hypertension and Nutrition, Geneva University 
      Hospitals, Geneva, Switzerland.
FAU - Pham, Truong-Thanh
AU  - Pham TT
AD  - Service of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
AD  - Orthopedic Surgery Service, Geneva University Hospitals, Geneva, Switzerland.
FAU - Kressmann, Benjamin
AU  - Kressmann B
AD  - Service of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
AD  - Orthopedic Surgery Service, Geneva University Hospitals, Geneva, Switzerland.
FAU - Jornayvaz, Francois R
AU  - Jornayvaz FR
AD  - Service of Endocrinology, Diabetes, Hypertension and Nutrition, Geneva University 
      Hospitals, Geneva, Switzerland.
FAU - Gastaldi, Giacomo
AU  - Gastaldi G
AD  - Service of Endocrinology, Diabetes, Hypertension and Nutrition, Geneva University 
      Hospitals, Geneva, Switzerland.
FAU - Stafylakis, Dimitrios
AU  - Stafylakis D
AD  - Orthopedic Surgery Service, Geneva University Hospitals, Geneva, Switzerland.
FAU - Philippe, Jacques
AU  - Philippe J
AD  - Service of Endocrinology, Diabetes, Hypertension and Nutrition, Geneva University 
      Hospitals, Geneva, Switzerland.
FAU - Lipsky, Benjamin A
AU  - Lipsky BA
AD  - Service of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
AD  - Department of Medicine, University of Washington, Seattle, Washington, USA.
FAU - Uckay, Lker
AU  - Uckay L
AD  - Service of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.
AD  - Orthopedic Surgery Service, Geneva University Hospitals, Geneva, Switzerland.
AD  - Infectiology, Balgrist University Hospital, University of Zurich, Zurich, 
      Switzerland.
AD  - Unit for Clinical and Applied Research, Balgrist University Hospital, University 
      of Zurich, Zurich, Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT03615807
GR  - Fondation pour la lutte contre le cancer et pour les recherches 
      medico-biologiques/
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Anti-Bacterial Agents)
SB  - IM
MH  - Aged
MH  - Anti-Bacterial Agents/therapeutic use
MH  - *Diabetes Mellitus/drug therapy
MH  - *Diabetic Foot/drug therapy/surgery
MH  - Female
MH  - Humans
MH  - Male
MH  - *Osteomyelitis/drug therapy
MH  - Pilot Projects
MH  - Prospective Studies
OTO - NOTNLM
OT  - adverse events
OT  - antibiotic duration
OT  - diabetic foot osteomyelitis
OT  - infection remission
OT  - randomized-controlled pilot trial
EDAT- 2020/11/27 06:00
MHDA- 2021/10/21 06:00
CRDT- 2020/11/26 12:08
PHST- 2020/07/10 00:00 [received]
PHST- 2020/11/27 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2020/11/26 12:08 [entrez]
AID - 6006875 [pii]
AID - 10.1093/cid/ciaa1758 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2021 Oct 5;73(7):e1539-e1545. doi: 10.1093/cid/ciaa1758.