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. 2021 Feb 26;2021(2):CD013099. doi: 10.1002/14651858.CD013099.pub2

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:
  • Males and females aged 3 to 80 years of age

  • Skin and soft tissue infection suspected as being caused by Staphylococcus aureus or by a mixed infection of Streptococcus pyogenes

  • Infection judged likely to heal after 10 days of treatment with 1 of the trial drugs


Exclusion criteria:
  • Known hypersensitivity to penicillin or cephalosporin

  • Treatment with antibiotic in the previous 72 h

  • Known renal impairment (creatinine > 160 µmol/L)

  • Known impaired liver function (aspartate amino transferase (ASAT) or alanine amino transferase(ASLT) ≥ twice the normal value)

  • Known immunodeficiency or treatment with immunosuppressive drugs such as steroids or cytostatics

  • Chronic leg ulcers, foot sores in diabetics, chronic fistula

  • Furuncles with acne‐related conditions such as suppurative hidradenitis

  • Previous participation in the study

  • Poor co‐operation


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.
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 
Outcomes
  1. Clinical efficacy: global clinical evaluation as "healed", "improved", and "unchanged or worse"

  2. Safety 

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.