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Caspofungin prophylaxis vs placebo, followed by preemptive Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study Multi-centre, double-blind, phase.

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Presentation on theme: "Caspofungin prophylaxis vs placebo, followed by preemptive Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study Multi-centre, double-blind, phase."— Presentation transcript:

1 Caspofungin prophylaxis vs placebo, followed by preemptive Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study 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) Pts randomised to: –Caspofungin: loading dose 70 mg iv, followed by 50 mg/d iv –Placebo: 0.9% saline iv FU: duration of ICU stay (max. 28 d) 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 Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26 1 of 3

2 Caspofungin prophylaxis vs placebo, followed by preemptive Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study Primary endpoint: Incidence of proven or probable IC in pts who did not have IC at baseline 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 Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26 2 of 3 Preemptive approach analysis: Including all pts receiving study drug, including pts with IC at baseline

3 Caspofungin prophylaxis vs placebo, followed by preemptive Tx for invasive candidiasis (IC) in ICU pts: MSG-01 study Safety No statistically significant ≠ between Tx arms 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 Ostrosky-Zeichner L et al. Clin Infect Dis 2014;58:1219-26 3 of 3 NI: not indicated


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