Transcript Oncoforum 2011 Template

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Caspofungin prophylaxis vs placebo, followed by preemptive
Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study
Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26
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Multi-centre, double-blind, phase IV RCT (USA): N=222 adults, staying in
ICU for ≥3 d, meeting following criteria (on any of d 1-3 of ICU admission):
– Being ventilated
– Receiving broad spectrum antibiotics
– Having a central venous catheter
– Having ≥1 additional risk factor: parenteral nutrition, dialysis, major
surgery*, pancreatitis*, systemic steroids or other immunosuppressants*
(*within 7 days prior to or on ICU admission)
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Pts randomised to:
– Caspofungin: loading dose 70 mg iv, followed by 50 mg/d iv
– Placebo: 0.9% saline iv
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FU: duration of ICU stay (max. 28 d)
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1,3-β-D-glucan (BG) levels monitored 2x/wk → pts with proven or probable
IC (EORTC/MSG criteria): break the blind + start preemptive Tx with
caspofungin in pts receiving placebo
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Caspofungin prophylaxis vs placebo, followed by preemptive
Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study
Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26
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Primary endpoint:
Incidence of proven or probable IC
in pts who did not have IC at baseline
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Secondary endpoints: no significant ≠ between Tx arms:
– Initiation of systemic antifungal Tx within 7 days of ending prophylaxis
– All-cause mortality within 7 days of ending prophylaxis
– Length of hospital stay, length of ICU stay
Preemptive approach analysis:
Including all pts receiving study drug,
including pts with IC at baseline
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Caspofungin prophylaxis vs placebo, followed by preemptive
Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study
Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26
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Safety
No statistically significant ≠ between Tx arms
NI: not indicated
Caspofungin appeared to be safe and tended to reduce the incidence of
IC vs placebo, when used for prophylaxis or preemptive Tx in
ICU patients