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. 2016 Jan 7;2016(1):CD008056. doi: 10.1002/14651858.CD008056.pub3

Wilcox 2009.

Methods Open‐label, multicentred, randomised study.
Participants Location: 100 centres in Europe, USA, Latin America and Asia.
 Time frame: May 2002‐May 2005.
 Inclusion criteria: patients ≥ 13 years, with a central venous, pulmonary artery, or arterial catheter in place for 13 days and suspected catheter‐related infection.
 Patient numbers: 726 randomised, 315 had cSSTI.
 Average age: Linezolid group: 53.7 years, Vancomycin group: 53.8 years; (for all study participants).
 Male:female ratio: Linezolid group: 202:161, Vancomycin group: 210:153 (for all study participants).
Interventions Linezolid group (n = 363, 164 SSTIs): linezolid 600 mg IV every 12 h; could be switched to oral.
 Vancomycin group (n = 363, 151 SSTIs): vancomycin 1 g IV every 12 h.
 Duration: 7–28 days for both groups.
Outcomes Clinical outcomes: assessed as "success" (cure with resolution of signs and symptoms or, at end of treatment only, improvement
 with moderate resolution of signs and symptoms and no additional antibiotic treatment); or "failure" (persistence or progression of clinical signs and symptoms or new clinical findings of infection).
Microbiological outcomes: assessed as "success" (documented or presumed eradication based on clinical outcome) or "failure"
 (documented or presumed persistence based on clinical failure and either missing microbiologic outcome or use of non‐study antibiotic because of lack of efficacy).
 Safety: all adverse events.
All cause mortality: 1‐2 weeks after treatment.
Notes For methicillin‐susceptible pathogens, vancomycin could be switched to oxacillin 2 g IV, or dicloxacillin 500 mg orally, each given every 6 h. Concomitant therapy allowed on the basis of susceptibility and local practice.
Quote: "M.H.W. has received honoraria for consultancy work, financial support to attend meetings, and research funding from Astra‐Zeneca, Bayer, Cerexa, Genzyme, Nabriva, Pfizer, Targanta, Vicuron"
 Comment: M.H.W was the lead author of the study report.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomly assigned".
 Comment: the method of sequence generation used in the trial was not reported.
Allocation concealment (selection bias) High risk Quote: "This was a open‐label, multicenter comparative study".
Comment: the trial had an open‐label design, and, therefore, was judged to be at high risk of bias.
Blinding (performance bias and detection bias) 
 All outcomes ‐ participants High risk Quote: "This was a open‐label, multicenter comparative study".
Comment: the trial had an open‐label design, and, therefore, was judged to be at high risk of bias.
Blinding (performance bias and detection bias) 
 All outcomes ‐ care givers High risk Quote: "This was a open‐label, multicenter comparative study".
Comment: the trial had an open‐label design, and, therefore, was judged to be at high risk of bias.
Blinding (performance bias and detection bias) 
 All outcomes ‐ outcome assessors High risk Quote: "This was a open‐label, multicenter comparative study".
Comment: the trial had an open‐label design, and, therefore, was judged to be at high risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes drop outs reported High risk dropouts (for all study participants):
 Linezolid group: 177/363 (48.8%); Vancomycin group: 179/363 (49.3%).
 Comments: reasons for dropouts were reported, but the levels were very high. In addition, the dropout rate was not clear for SSTIs, therefore, this was judged to be at high risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes ITT analysis reported High risk 726 randomised, 422 included in analysis for all study participants.
315 randomised, 296 included in analysis for SSTIs.
 Comment: ITT was not undertaken.
Selective reporting (reporting bias) Unclear risk Comment: the study protocol is not available and trial authors did not stated whether the published reports included all expected outcomes.
Other bias Low risk No other biases identified.