A Phase 3 interventional study of Standard of Care (SOC) and Shortened duration of antifungal therapy in CANDIDEMIA, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's planned enrollment of 362 is above the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Standard of Care (SOC)
Drug: Shortened duration of antifungal therapy
14 days of antifungal therapy after the 1st negative blood culture
7 days of antifungal therapy after the 1st negative blood culture
All-cause mortality (ACM)
at day 28 after the 1st negative blood culture under antifungal treatment for all patients included with an uncomplicated candidemia
Time frame: At day 28
Proportion of patients with secondary localizations
Time frame: At day 28
Cumulative incidence of death related to fungal infection
at Day 28 after the 1st negative blood culture under antifungal treatment
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
Incremental cost effectiveness ratio
Time frame: Up to day 28
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for Sep 2027, 26 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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