Nicolau 1999a.
Methods | Prospective, single‐blind, randomised trial. | |
Participants | 34 critical care patients (mean age range 43 to 51 years; 65% male) with nosocomial pneumonia (pg. 134). Exclusion: not stated. |
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Interventions | Ceftazidime 2 g i.v. q8h infused over 30 minutes vs ceftazidime 1 g i.v. loading dose over 30 minutes, followed by 3 g continuous infusion over 24 h (both groups received concomitant tobramycin 7 mg/kg i.v. daily); treatment duration not stated. | |
Outcomes | Pharmacokinetic parameters (Cmax, Cmin, K, t1/2, AUC, clearance). Pharmacodynamic profile. Follow‐up between days 2 and 5 of therapy. |
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Notes | Pharmacokinetic study, clinical outcomes not stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, but randomisation method not stated (pg. 134). |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Single blind, but unclear which group was blinded (pg. 134). |
Incomplete outcome data (attrition bias) All outcomes | High risk | Data were acquired from 41 participants, but only 34 participants were included in analysis; reasons for exclusion not stated (pg. 134). |
Selective reporting (reporting bias) | High risk | Outcomes not specified a priori reported (Cmean, isolated pathogens, T > MIC) (pg. 136‐7). "All patients tolerated the continuous infusions with no infusion‐related adverse effects (e.g. phlebitis)" (pg. 136); however, adverse events for the intermittent group were not reported. |
Other bias | Unclear risk | Baseline imbalance, intermittent participants older (mean age 51 years vs 43 years). Funded by Glaxo Pharmaceuticals (pg. 139). |