Lubasch 2003.
Methods | Multicentre, randomised trial. | |
Participants | 81 hospitalised patients (mean age 65 years; 69% male) with acute exacerbation of severe chronic bronchitis, Exclusion: pregnancy or lactation period, allergy to beta‐lactams and/or aminoglycosides, other infection requiring systemic antibiotics, last dose of antibiotic < 72 h, impaired renal function. |
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Interventions | Ceftazidime 2 g i.v. q8h vs ceftazidime 2 g i.v. loading dose, followed by 2 g i.v. infused over 7 h q12h; treatment duration 8 to 14 days. | |
Outcomes | Clinical and bacteriological responses at day 8 or 9, and 72 h after the end of therapy. Pharmacokinetic and pharmacodynamic parameters of ceftazidime, |
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Notes | Extended interval. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomly assigned, but randomisation method not stated (pg. 670). |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding (performance bias and detection bias) All outcomes | High risk | Open label. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Outcomes reported for clinically evaluable population, but number of patients in clinically evaluable population not stated (pg. 661). |
Selective reporting (reporting bias) | Low risk | Reported on all pre‐specified outcomes of interest. |
Other bias | Unclear risk | Not all patients were assessed for clinical outcomes, reason for exclusion of patients from clinically evaluable population not stated. Clinical success was defined as cure or improvement. |