Buck 2005.
Methods | Prospective, open‐label, randomised trial. | |
Participants | 24 hospitalised participants (age range 41 to 76 years; 58% male) with community‐ or hospital‐acquired infections (late‐onset hospital‐acquired pneumonia, severe community‐acquired pneumonia, severe urinary tract infection, cholangitis in participants with risk factors, complicated peritonitis, participants at risk with fever of unknown origin). Exclusion: lack of informed consent, pregnancy or lactation in women, known hypersensitivity or intolerance to piperacillin‐tazobactam, and epilepsy. |
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Interventions | Piperacillin/tazobactam 2 g/0.5 g i.v. bolus loading dose, given over 1 h, followed by 8 g/1 g i.v. over 23 h on day 1, then over 24 h vs piperacillin 4 g + tazobactam 0.5 g i.v. q8h (doses were adjusted in those with renal dysfunction); mean treatment duration not stated. | |
Outcomes | Pharmacokinetic analysis: serum concentration‐time profiles. Clinical assessment and response (clinical or bacteriological success). |
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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 | Concealment via envelopes, but opacity of envelopes not stated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants and clinicians were not blind. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomly assigned participants were accounted for at study end. |
Selective reporting (reporting bias) | Unclear risk | Clinical assessment was not the primary outcome (not assessed systematically in every participant). Reported all pre‐specified outcomes of interest. |
Other bias | Unclear risk | Other antibiotics were permitted. Sponsored by Wyeth Lederle. |