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. 2013 Mar 28;2013(3):CD008481. doi: 10.1002/14651858.CD008481.pub2

DeJongh 2008.

Methods Prospective, unblinded, randomised trial. 
Participants 17 participants (mean age 57 years; 75% male) with a high probability of infection from nosocomial origin, and no suspicion of infection ofPseudomonas spp. or other temocillin‐resistant bacteria.
Exclusion: age < 18 or > 75 years, weight < 50 or > 100 kg, renal insufficiency (estimated clearance < 45 mL/min), hemodialysis, estimated survival < 5 days, documentation of temocillin‐resistant organism, meningitis or other proven infection of the CNS, IgE‐mediated allergy to penicillins, severe granulocytopenia, pregnancy, participants having participated in another study < 30 days before, and marked deterioration of renal function during the study period.
Interventions Temocillin 2 g i.v. loading dose given over 30 minutes, followed by 4 g i.v. infused at a rate of 2 mL/min vs temocillin 2 g i.v. given over 30 minutes q12h (all participants received flucloxacillin (six times 1 g/day)); mean treatment duration 8.5 to 8.8 days.
Outcomes PK/PD breakpoints.
Stability and compatibility studies.
MIC with E. coli.
PK analyses.
Population PK.
Probability of target attainment rate.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomly assigned, but method of randomisation was not stated.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding (performance bias and detection bias) 
 All outcomes High risk Not blind.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 4 participants in the intermittent i.v. group were considered clinically not evaluable; no information on their outcome is provided, and it is unclear whether they were considered failure or cure.
Selective reporting (reporting bias) Unclear risk Reported on all pre‐specified outcomes of interest (except clinical outcomes were not specified a priori-were reported as favourable).
Other bias Unclear risk SC is supported by a First‐Entreprise grant awarded by the Direction Generale de la Recherche et des Technologies of the Region Wallonne; also supported by the Belgian Fonds de la Recherche Scientifique Medicale and by a grant‐in‐aid from Eumedica S.A., Brussels, Belgium.
SC is working under contract with Eumedica s.a., Brussels, Belgium, and RDJ and PMT are unpaid advisors to Eumedica s.a., Brussels, Belgium.