CANDIDEMIAPhase 3CANDISHORTNCT06859671
A Randomized Study of a Short Duration Therapy for Candidemia
A Phase 3 study testing Shortened duration of antifungal therapy in people with CANDIDEMIA, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CANDIDEMIA
- What is being tested?
- Shortened duration of antifungal therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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
- Being tested
- Standard of Care (SOC), Shortened duration of antifungal therapy
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Drug
14 days of antifungal therapy after the 1st negative blood culture
Shortened duration of antifungal therapyDrug
7 days of antifungal therapy after the 1st negative blood culture
| Study group | Role | What they receive |
|---|---|---|
| 14 days of antifungal treatment | Active comparator | Not described Receives: Drug: Standard of Care (SOC) |
| 7 days of antifungal treatment | Experimental | Not described Receives: Drug: Shortened duration of antifungal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (ACM)
at day 28 after the 1st negative blood culture under antifungal treatment for all patients included with an uncomplicated candidemia
Measured: At day 28
Secondary outcomes (11)
Proportion of patients with secondary localizations
Measured: At day 28
Cumulative incidence of death related to fungal infection
at Day 28 after the 1st negative blood culture under antifungal treatment
Measured: At day 28
Aspartate Amino-transferase level
Measured: At day 14
Aspartate Amino-transferase level
Measured: At day 28
alanine aminotransférase (ALAT) level
Measured: At day 14
alanine aminotransférase (ALAT) level
Measured: At day 28
Gamma-Glutamyl Transférase (GGT) level
Measured: At day 14
Gamma-Glutamyl Transférase (GGT) level
Measured: At day 28
Bilirubin blood levels
Measured: At day 14
Bilirubin blood levels
Measured: At day 28
Cost per extra-day alive without antifungal treatment
Incremental cost effectiveness ratio
Measured: Up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CANDIDEMIAStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Design of the study Multicenter, controlled, randomized, non-inferiority, clinical trial with 2 parallel groups (1:1)
- Masking
- None (open label)
- Enrolment
- 362 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859671
- Sponsor's protocol ID
- APHP230824
- Acronym
- CANDISHORT
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of a Short Duration Therapy for Candidemia
- ClinicalTrials.gov ID
- NCT06859671
- Acronym / sponsor ID
- CANDISHORT / APHP230824
- Conditions
- CANDIDEMIA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Design of the study Multicenter, controlled, randomized, non-inferiority, clinical trial with 2 parallel groups (1:1)
| Arm | Type | Receives |
|---|---|---|
| 14 days of antifungal treatment | Active comparator | Drug: Standard of Care (SOC) |
| 7 days of antifungal treatment | Experimental | Drug: Shortened duration of antifungal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)14 days of antifungal therapy after the 1st negative blood culture | Drug | 14 days of antifungal treatment |
| Shortened duration of antifungal therapy7 days of antifungal therapy after the 1st negative blood culture | Drug | 7 days of antifungal treatment |
Primary outcome
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
11 secondary outcomes
Proportion of patients with secondary localizations
Time frame: At day 28
Cumulative incidence of death related to fungal infection
Time frame: At day 28
Aspartate Amino-transferase level
Time frame: At day 14
Aspartate Amino-transferase level
Time frame: At day 28
alanine aminotransférase (ALAT) level
Time frame: At day 14
alanine aminotransférase (ALAT) level
Time frame: At day 28
Gamma-Glutamyl Transférase (GGT) level
Time frame: At day 14
Gamma-Glutamyl Transférase (GGT) level
Time frame: At day 28
Bilirubin blood levels
Time frame: At day 14
Bilirubin blood levels
Time frame: At day 28
Cost per extra-day alive without antifungal treatment
Time frame: Up to day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shortened duration of antifungal therapy in people with CANDIDEMIA, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blandine Denis, MD (+33142494585 ext. +33, blandine.denis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (ACM) (time frame: At day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.