A Randomized Study of a Short Duration Therapy for Candidemia

NCT06859671 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APHP230824
• Study Type: interventional
• Target: 362
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

CANDIDEMIA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Proportion of patients with secondary localizations

  At day 28

• Cumulative incidence of death related to fungal infection

  At day 28

• Aspartate Amino-transferase level

  At day 14

• Aspartate Amino-transferase level

  At day 28

• alanine aminotransférase (ALAT) level

  At day 14

Study Arms (2)

14 days of antifungal treatment

ACTIVE COMPARATOR

Drug: Standard of Care (SOC)

7 days of antifungal treatment

EXPERIMENTAL

Drug: Shortened duration of antifungal therapy

Interventions

Standard of Care (SOC) DRUG

14 days of antifungal therapy after the 1st negative blood culture

14 days of antifungal treatment

Shortened duration of antifungal therapy DRUG

7 days of antifungal therapy after the 1st negative blood culture

7 days of antifungal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (Age ≥ 18 years old)
• With an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis.
• Without expected aplasia duration greater than 7 days
• Being apyretic and having a 1st negative blood culture after diagnosis
• Removal of the vascular catheter if present
• Written informed consent from the patients or his/her relatives
• Patients with less than 7 days of aplasia predictable

You may not qualify if:

• Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment
• Patients with more than 7 days of aplasia
• Candida strain resistant to the antifungal used
• Pregnancy, breastfeeding
• Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments.
• unwilling, in the judgment of the investigator, to comply with the protocol
• Patient under legal guardianship or without healthcare coverage
• Women with childbearing potential not using adequate contraception

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Candidemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Blandine Denis, MD

CONTACT

+33142494585; blandine.denis@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

+33 1 42 49 97 42; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Design of the study Multicenter, controlled, randomized, non-inferiority, clinical trial with 2 parallel groups (1:1)

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02