Beitner 1996.
Study characteristics | ||
Methods | A randomised, single‐blind, multicentre trial | |
Participants | Country: Sweden Setting: hospital Study periods: 18 December 1992 to 16 November 1994 Inclusion criteria:
Exclusion criteria:
A total of 661 participants, aged 3 to 81 years old, enrolled in the study, and 642 in the intention‐to‐treat analysis of efficacy; only 327 of them (41 with furunculosis, 21 taking cefadroxil and 20 taking flucloxacillin) were included in the primary analysis of efficacy, and 651 for adverse events assessment. |
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Interventions | Cefadroxil group: oral cefadroxil tablets or suspension 40 mg/kg to a maximum dose of 1 g once daily for 10 days Flucloxacillin group: oral flucloxacillin 750 mg tablets twice daily or suspension 30 to 50 mg/kg administered in 2 or 3 daily doses to a maximum dose of 1.5 g for 10 days |
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Outcomes |
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Funding source | Bristol‐Myers Squibb | |
Declarations of interest | Not reported | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "In this prospective single‐blind, comparative and randomized, multicentre trial" Comment: the method was not described. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The database was closed and [a] clean file declared on 7 December 1994." Comment: the method of allocation was not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "For 10 days one group took cefadroxil (Cefamox, Bristol‐Myers Squibb) tablets or suspension 40 mg/Kg to a maximum dose of 1g once daily, while the other group took flucloxacillin (Heracillin, Astra) 750 mg tablets twice daily or suspension 30‐50 mg/kg administered in two or three daily doses to a maximum dose of 1.5g." Comment: the frequency and brand of medicine differed. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: there was no description of the blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The intention‐to‐treat data were unavailable, and the outcome efficacy analysis was according to pre‐protocol data. |
Selective reporting (reporting bias) | Low risk | Both efficacy and adverse events were reported. |
Other bias | Unclear risk | There was insufficient information to assess whether an important risk of bias existed. |