Invasive Candidiasis Clinical Trial
Official title:
Impact of the Use of Biomarkers on Early Discontinuation of Empirical Antifungal Therapy in Critically Ill Patients: a Randomized Controlled Study.
Empirical antifungal therapy (EAT) is frequently prescribed to septic critically ill patients with risk factors for invasive Candida infections (ICI). However, among patients without subsequent proven ICI, antifungal discontinuation is rarely performed, resulting in unnecessary antifungal overuse. The investigators postulate that the use of fungal biomarkers could increase the percentage of early discontinuation of EAT among critically ill patients suspected of ICI, as compared with a standard strategy, without negative impact on day 28-mortality. To test this hypothesis, the investigators designed a randomized controlled open-label parallel-group study.
Patients requiring EAT will be randomly assigned to: - intervention group: a strategy in which EAT duration is determined by (1,3)-B-Dglucan and mannan serum assays, performed on day 0 (day of EAT initiation) and day 3. Early stop recommendation, provided before day 7, will be determined using an algorithm based on the results of biomarkers. - control group: a routine care strategy, based on international guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05763251 -
Comparison of Uncomplicated Candidemia Therapy Duration in Children
|
N/A | |
| Recruiting |
NCT01438216 -
Anidulafungin Pharmacokinetics in Intensive Care Unit Patients
|
N/A | |
| Terminated |
NCT01213823 -
Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
|
Phase 4 | |
| Completed |
NCT02491151 -
Variability of Fluconazole Concentration in Critically Ill Patients
|
N/A | |
| Completed |
NCT01716988 -
Pharmacokinetics of Micafungin in Critically Ill Patients
|
N/A | |
| Completed |
NCT00607763 -
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
|
Phase 1 | |
| Completed |
NCT00608335 -
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
|
Phase 1 | |
| Completed |
NCT00786903 -
Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen?
|
N/A | |
| Completed |
NCT00670657 -
CRITIC - Treatment of Candidemia and Invasive Candidiasis
|
Phase 4 | |
| Recruiting |
NCT04368559 -
Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
|
Phase 3 | |
| Not yet recruiting |
NCT05707832 -
A Study of ABCD for Injection in Subjects With Invasive Candidiasis and Invasive Aspergillus
|
Phase 3 | |
| Completed |
NCT02801682 -
NOBICS - NOvel BIomarker In Invasive CandidiasiS/Candida Sepsis
|
||
| Completed |
NCT02164890 -
Pharmacokinetics of Micafungin in Patients of Intensive Care Units
|
Phase 4 | |
| Completed |
NCT02841501 -
Genetic Susceptibility Factors for Candidemia.
|
||
| Completed |
NCT01047267 -
Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)
|
N/A | |
| Completed |
NCT00672841 -
β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
|
N/A | |
| Completed |
NCT02734862 -
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
|
Phase 2 | |
| Completed |
NCT01773876 -
Empirical Antifungal Treatment in ICUS
|
Phase 3 | |
| Completed |
NCT00689338 -
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
|
Phase 3 | |
| Terminated |
NCT03906916 -
Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin
|
Phase 4 |