A multicenter, randomized, double-blind, placebo-controlled, adaptive, non-inferiority trial to investigate shortening treatment duration in uncomplicated candidemia: the CanTEN trial

Conditions

Candidemia

Brief summary

Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37).

Detailed description

Time from randomization to recurrent candidemia and/or other proven invasive candidiasis., Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7)., Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37)., All-cause mortality at 30 days after end of study treatment (Day 37)., Mortality attributable to candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB., Candidemia-attributable healthcare resources at 30 days after end of study treatment, including length of stay in ICU or IMC or general ward, duration of mechanical ventilation, cost of antifungal therapy since onset of candidemia., Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin., Patient reported outcome measures (PROMs) on Day 1 and Day 37: Health-related quality of life as per EQ-5D-5L , Physical functioning as per WHODAS 2.0.

Related papers

No related papers found yet.

Interventions

DRUGSODIUM LACTATE

DRUGCASPOFUNGIN ACETATE

DRUGSALINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of recurrent candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment (Day 37).	—

Secondary

Measure	Time frame
Time from randomization to recurrent candidemia and/or other proven invasive candidiasis., Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7)., Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37)., All-cause mortality at 30 days after end of study treatment (Day 37)., Mortality attributable to candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB., Candidemia-attributable healthcare resources at 30 days after end of study treatment, including length of stay in ICU or IMC or general ward, duration of mechanical ventilation, cost of antifungal therapy since onset of candidemia., Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin., Patient reported outcome measures (PROMs) on Day 1 and Day 37: Health-related quality of life as per EQ-5D-5L , Physical functioning a	—

Measure

Time frame

Time from randomization to recurrent candidemia and/or other proven invasive candidiasis., Clinical cure, radiological cure and mycological eradication at end of study treatment (Day 7)., Clinical cure, radiological cure and mycological eradication at 30 days after end of study treatment (Day 37)., All-cause mortality at 30 days after end of study treatment (Day 37)., Mortality attributable to candidemia and/or other proven invasive candidiasis at 30 days after end of study treatment, as determined by the DSMB., Candidemia-attributable healthcare resources at 30 days after end of study treatment, including length of stay in ICU or IMC or general ward, duration of mechanical ventilation, cost of antifungal therapy since onset of candidemia., Caspofungin-related adverse events (AEs) occurring until 30 days after last administration of caspofungin., Patient reported outcome measures (PROMs) on Day 1 and Day 37: Health-related quality of life as per EQ-5D-5L , Physical functioning a

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Outcome results

None listed