Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Scientific justification Candidemia is a major public health problem. In France, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years.
The duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the Rex trial (1) comparing the efficacy of fluconazole vs amphotericin B where the minimum duration of treatment was imposed. The risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic.
A retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21/78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. In addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity.
There is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14 days of antifungal treatment | Active Comparator |
| |
| 7 days of antifungal treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (SOC) | Drug | 14 days of antifungal therapy after the 1st negative blood culture |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality (ACM) | at day 28 after the 1st negative blood culture under antifungal treatment for all patients included with an uncomplicated candidemia | At day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with secondary localizations | At day 28 | |
| Cumulative incidence of death related to fungal infection | at Day 28 after the 1st negative blood culture under antifungal treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blandine Denis, MD | Contact | +33142494585 | +33 | blandine.denis@aphp.fr |
| Jérôme Lambert, MD PhD | Contact | +33 1 42 49 97 42 | +33 | jerome.lambert@u-paris.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058387 | Candidemia |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Design of the study Multicenter, controlled, randomized, non-inferiority, clinical trial with 2 parallel groups (1:1)
Not provided
Not provided
Not provided
Not provided
| Shortened duration of antifungal therapy | Drug | 7 days of antifungal therapy after the 1st negative blood culture |
|
| At day 28 |
| Aspartate Amino-transferase level | At day 14 |
| Aspartate Amino-transferase level | At day 28 |
| alanine aminotransférase (ALAT) level | At day 14 |
| alanine aminotransférase (ALAT) level | At day 28 |
| Gamma-Glutamyl Transférase (GGT) level | At day 14 |
| Gamma-Glutamyl Transférase (GGT) level | At day 28 |
| Bilirubin blood levels | At day 14 |
| Bilirubin blood levels | At day 28 |
| Cost per extra-day alive without antifungal treatment | Incremental cost effectiveness ratio | Up to day 28 |
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |