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Clinical Trials in the EU / 2024-514244-81-00
Authorised Phase III

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

2024-514244-81-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
06/03/2026
Enrollment target
399
Sites
France

Condition studied

Uncomplicated candidemia

Investigational medicinal product(s)

ANIDULAFUNGINMICAFUNGINMICAFUNGINAMPHOTERICINE BLIPOSOMECASPOFUNGINCASPOFUNGINVORICONAZOLEAMPHOTERICINE BLIPOSOMEFLUCONAZOLEVORICONAZOLEANIDULAFUNGINFLUCONAZOLE

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

Proportion of randomized patients with secondary localizations at Day 28 (+/- 2 days), 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), Incremental cost effectiveness ratio : cost per extra-day alive without antifungal treatment up to D45 (+/- 2 days) (Visit 5) if patients still hospitalized.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-514244-81-00 on CTIS ↗ ← All trials in the EU