CANDISHORT : A randomized study of a short duration therapy for candidemia

Conditions

Uncomplicated candidemia

Brief summary

The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.

Detailed description

Proportion of randomized patients with secondary localizations, Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture, Liver function tests (ASAT, ALAT, GGT, PAL, bilirubin blood levels) according to the two treatment strategies at inclusion (Visit 1) randomization (Visit 2), at D14 (+/- 2 days) (Visit 3) (D1: day of the 1st drawn negative blood culture), Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized, Proportion of randomized patients with relapse at D45 (+/- 2 days), Proportion of randomized patients with secondary localization at D45 (+/- 2 days)

Related papers

No related papers found yet.

Interventions

DRUGVORICONAZOLE

DRUGANIDULAFUNGIN

DRUGCASPOFUNGIN

DRUGAMPHOTERICINE B

DRUGLIPOSOME

DRUGFLUCONAZOLE

DRUGMICAFUNGIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The Primary endpoint will be ACM at Day 28 (+/- 2 days) after the 1st negative blood for all randomized patients under antifungal treatment with a diagnosis of uncomplicated candidemia.	—

Secondary

Measure	Time frame
Proportion of randomized patients with secondary localizations, Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture, Liver function tests (ASAT, ALAT, GGT, PAL, bilirubin blood levels) according to the two treatment strategies at inclusion (Visit 1) randomization (Visit 2), at D14 (+/- 2 days) (Visit 3) (D1: day of the 1st drawn negative blood culture), Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized, Proportion of randomized patients with relapse at D45 (+/- 2 days), Proportion of randomized patients with secondary localization at D45 (+/- 2 days)	—

Measure

Time frame

Proportion of randomized patients with secondary localizations, Cumulative incidence of death related to fungal infection at Day 28 (+/- 2 days) after the 1st negative blood culture, Liver function tests (ASAT, ALAT, GGT, PAL, bilirubin blood levels) according to the two treatment strategies at inclusion (Visit 1) randomization (Visit 2), at D14 (+/- 2 days) (Visit 3) (D1: day of the 1st drawn negative blood culture), Incremental cost effectiveness ratio: cost per extra-day alive without antifungal treatment up to D28 (+/- 2 days) (Visit 4) if patients still hospitalized, Proportion of randomized patients with relapse at D45 (+/- 2 days), Proportion of randomized patients with secondary localization at D45 (+/- 2 days)

—

Outcome results

None listed