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Clinical Summary

Prophylactic levofloxacin shows benefits in newly diagnosed myeloma

Takeaway

  • In patients with newly diagnosed myeloma, the addition of prophylactic levofloxacin to active myeloma treatment significantly reduced febrile episodes and the number of deaths without increasing healthcare-associated infections (HCAIs) or carriage.

Why this matters

  • Findings support the use of prophylactic levofloxacin for patients undergoing antimyeloma treatment.

Study design

  • TEAMM study of 977 patients with newly diagnosed myeloma who were randomly assigned (1:1) to receive levofloxacin (500 mg; n=489) and placebo (n=488).
  • Primary outcome: time to first febrile episode or death in the first 12 weeks.
  • Funding: Health Technology Assessment programme of National Institute for Health Research.   

Key results

  • Levofloxacin group had a significant reduction in the incidence of febrile episode or death vs placebo group within the first 12 weeks  (95 vs 134; HR, 0.66; 95% CI, 0.51-0.86; P=.002).
  • Risk for non-febrile infection episodes was also lower in levofloxacin vs placebo group (144 vs 179; P-trend=.06).
  • No difference was observed in new acquisitions of Clostridium difficile, methicillin-resistant Staphylococcus aureus and extended-spectrum β-lactamase Gram-negative organisms up to 16 weeks.
  • With a median follow-up of 52 weeks, no significant difference was observed in overall survival between levofloxacin and placebo group (P=.94).

Limitations

  • Risk of selection bias.

References


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