Sakka 2007.
Methods | Prospective, randomised trial. | |
Participants | 20 surgical intensive care unit patients (mean age range 59 to 62 years; 55% male) with ICU‐acquired pneumonia (duration of endotracheal intubation and mechanical ventilation > 3 days). Exclusion: not stated. |
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Interventions | Imipenem‐cilastatin 1 g/1 g i.v. given over 40 minutes, followed by 2 g/2 g continuously infused q24h for 3 days (thereafter, 1 g/1 g i.v q8h) vs imipenem‐cilastatin 1 g/1 g i.v. given over 40 minutes three times daily for 3 days; mean treatment duration 12 to 14 days. | |
Outcomes | Pharmacokinetic analysis. Pharmacodynamic analysis. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, but method of randomisation is unclear. |
Allocation concealment (selection bias) | Low risk | "The randomisation code was provided to the clinical investigator in sealed envelopes" (pg. 3306), but there is no mention of the opaqueness of envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated, likely not blind. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Participants lost to follow‐up or withdrawn from study not stated (although mortality reported over a denominator of 20 participants). |
Selective reporting (reporting bias) | High risk | Reported on outcomes not specified a priori (imipenem‐related adverse reactions, mortality). |
Other bias | Unclear risk | "Antibiotic pretreatment was given to eight patients in the short‐term infusion group (four patients pretreated with ceftriaxone, one with cefuroxime, two with piperacillin‐tazobactam, and one with moxifloxacin). For comparison, nine patients in the continuous group received antibiotic therapy before administration of imipenem‐cilastatin (four patients pretreated with ceftriaxone, two with cefuroxime, two with piperacillin‐tazobactam, and one with cefepime) (pg. 3306). Funded by MDS Sharp & Dohme (pg. 3309). Author conflict of interest not stated. |