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NCT Number: NCT06859671

A Randomized Study of a Short Duration Therapy for Candidemia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Standard of Care (SOC)

Drug

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

Shortened duration of antifungal therapy

Drug

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

Primary outcomes

  1. All-cause mortality (ACM)

    Time frame: At day 28

    at day 28 after the 1st negative blood culture under antifungal treatment for all patients included with an uncomplicated candidemia

Secondary outcomes

  1. Proportion of patients with secondary localizations

    Time frame: At day 28

  2. Cumulative incidence of death related to fungal infection

    Time frame: At day 28

    at Day 28 after the 1st negative blood culture under antifungal treatment

  3. Aspartate Amino-transferase level

    Time frame: At day 14

  4. Aspartate Amino-transferase level

    Time frame: At day 28

  5. alanine aminotransférase (ALAT) level

    Time frame: At day 14

  6. alanine aminotransférase (ALAT) level

    Time frame: At day 28

  7. Gamma-Glutamyl Transférase (GGT) level

    Time frame: At day 14

  8. Gamma-Glutamyl Transférase (GGT) level

    Time frame: At day 28

  9. Bilirubin blood levels

    Time frame: At day 14

  10. Bilirubin blood levels

    Time frame: At day 28

  11. Cost per extra-day alive without antifungal treatment

    Time frame: Up to day 28

    Incremental cost effectiveness ratio

Study contacts

Contact information is provided by the study sponsor or research team.

Blandine Denis, MD

CONTACT

[email protected]

+33142494585 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

+33 1 42 49 97 42 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CANDISHORT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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