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