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. |
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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. |
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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. |