Study summary: Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure

Timsit J-F. JAMA 2016; 316(5): 1555-1564.

Clinical Question

  • In critically ill patients with non-neutropenic sepsis, multiple Candida colonisation and multi organ failure, does empirical micafungin therapy increase invasive fungal infection-free survival at day 28 compared with placebo?

Authors’ Conclusions

  • Among non-neutropenic critically ill patients with ICU acquired sepsis, Candida species colonisation at multiple sites, and multiple organ failure, empirical treatment with micafungin compared with placebo did not increase fungal infection-free survival at day 28

Strengths

  • Large study investigating the effect of empirical anti-fungal treatment
  • Multicentre performed across university-affiliated and non-university hospitals, adding to it’s external validity
  • Appropriately powered
  • Allocation concealment
  • Blinding achieved by pharmacy producing opaque bags containing micafungin or placebo
  • Statistical analyses used on secondary end points were predefined
  • No patients lost to follow up
  • Registered on clinicaltrials.gov
  • An homogenous group of patients were selected, which improves the internal validity of the trial

Weaknesses

  • Such an homogenous group of patients is highly selective and fairly uncommon; demonstrated by the fact it took 19 ICUs 3 years to recruit 260 patients – which averages at 4 patients per site per year
  • General ICU management (such as lung protective ventilation) was not standardised between groups or between units – affecting the internal and external validity of the trial

The Bottom Line

  • This study does not support empirical anti-fungal therapy with micafungin in a select group of intensive care patients at high risk of invasive candidiasis

Read the full summary here.

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