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Last Updated: November 8, 2024

CLINICAL TRIALS PROFILE FOR FLUCONAZOLE


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505(b)(2) Clinical Trials for FLUCONAZOLE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Institutul Clinic Fundeni Bucharest Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Dosage NCT02372357 ↗ A New Dosing Regimen for Posaconazole Prophylaxis in Children Based on Body Surface Area Completed Universitaire Ziekenhuizen Leuven Phase 4 2012-02-01 A new prophylactic posaconazole dosing regimen of 120mg/m² tid is evaluated pharmacologically in children 13 years and younger, suffering from a hematologic malignancy.
New Indication NCT04495608 ↗ Fluconazole in Hypercalciuric Patients With Increased 1,25(OH)2D Levels Recruiting Hospices Civils de Lyon Phase 2 2021-01-13 Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: - the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, - the evolution of renal function, - the cohort at Baseline and after 4 months of treatment period, - the safety of fluconazole, - the onset of potential mycological resistances, - and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 50 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for FLUCONAZOLE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000627 ↗ Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome Completed Pfizer N/A 1969-12-31 To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000627 ↗ Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the use of fluconazole as (1) induction therapy in histoplasmosis, (2) maintenance therapy to prevent relapse of histoplasmosis. Histoplasmosis is a serious opportunistic infection in patients with AIDS. Fluconazole is a triazole antifungal agent that has been used successfully in the treatment of experimental histoplasmosis in animals, but has not been completely evaluated in patients for this use. It has been approved by the Food and Drug Administration for certain other fungal infections. Nevertheless, physicians are prescribing it to their patients with histoplasmosis. This is a pilot study to examine the role of fluconazole for treating histoplasmosis in AIDS patients.
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed Washington University School of Medicine N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
NCT00000639 ↗ A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the effectiveness and safety of amphotericin B plus flucytosine (5-fluorocytosine) compared to amphotericin B alone for a first episode of acute cryptococcal meningitis in AIDS patients, and to compare the effectiveness and safety of fluconazole versus itraconazole. At least 10 percent of patients with a low CD4 count and HIV infection will develop meningitis due to Cryptococcus neoformans. More effective treatments than the standard therapy need to be explored.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLUCONAZOLE

Condition Name

Condition Name for FLUCONAZOLE
Intervention Trials
HIV Infections 42
Candidiasis 21
Mycoses 19
Meningitis, Cryptococcal 16
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Condition MeSH

Condition MeSH for FLUCONAZOLE
Intervention Trials
Candidiasis 77
HIV Infections 45
Mycoses 44
Infections 31
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Clinical Trial Locations for FLUCONAZOLE

Trials by Country

Trials by Country for FLUCONAZOLE
Location Trials
United States 766
China 33
Canada 28
Spain 18
Belgium 15
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Trials by US State

Trials by US State for FLUCONAZOLE
Location Trials
California 57
Texas 53
Florida 46
New York 45
Pennsylvania 39
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Clinical Trial Progress for FLUCONAZOLE

Clinical Trial Phase

Clinical Trial Phase for FLUCONAZOLE
Clinical Trial Phase Trials
Phase 4 32
Phase 3 57
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for FLUCONAZOLE
Clinical Trial Phase Trials
Completed 183
Unknown status 21
Recruiting 20
[disabled in preview] 19
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Clinical Trial Sponsors for FLUCONAZOLE

Sponsor Name

Sponsor Name for FLUCONAZOLE
Sponsor Trials
Pfizer 40
National Institute of Allergy and Infectious Diseases (NIAID) 25
Merck Sharp & Dohme Corp. 7
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Sponsor Type

Sponsor Type for FLUCONAZOLE
Sponsor Trials
Other 212
Industry 161
NIH 46
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