CLINICAL TRIALS PROFILE FOR FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Fluconazole In Dextrose 5% In Plastic Container

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.
OTC	NCT05059145 ↗	A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis	Not yet recruiting	Karolinska Institutet	Phase 2	2021-10-01	The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane®) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane® is approved during pregnancy and the cream is usually well tolerated. Our research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.

All Clinical Trials for Fluconazole In Dextrose 5% In Plastic Container

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.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	Pfizer	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000676 ↗	Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To study the effectiveness, safety, and tolerance of fluconazole versus clotrimazole troches (lozenges) as prophylaxis (preventive treatment) against fungal infections in patients enrolled in ACTG 081 (a study of prophylaxis against pneumocystosis, toxoplasmosis, and serious bacterial infection). Primarily, to compare the rates of invasive infections by C. neoformans, endemic mycoses, and Candida. To compare the mortality rates due to fungal infections between two antifungal prophylactic treatments. Secondarily, to assess the effect of prophylaxis on the incidence of severe fungal infections, defined as invasive infections and esophageal candidiasis and less severe mucocutaneous infection. Serious fungal infections are significant complicating and life-threatening occurrences in patients with advanced HIV infection. Oropharyngeal candidiasis is found in almost all such patients, and causes pain, difficulty in swallowing, and loss of appetite. Similarly, esophageal candidiasis causes illness in the population. Cryptococcosis, endemic mycoses, and coccidioidomycosis also cause significant illness and death in AIDS patients. Once established, fungal infections in AIDS patients generally require continuous suppressive therapy because attempts at curing these infections are usually unsuccessful. Fluconazole has a number of characteristics that would make it a logical candidate to examine as a prophylactic agent in patients with advanced HIV infection. Animal studies have shown it to be prophylactic in models of candidiasis, cryptococcosis, histoplasmosis, and coccidioidomycosis. Initial experience in patients with active cryptococcal meningitis appears favorable, and studies of oropharyngeal candidiasis show it to be effective.
NCT00000708 ↗	Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the safety and effectiveness of fluconazole (FCZ) and amphotericin B (AMB), alone or in combination with flucytosine (FLC), as treatment for acute cryptococcal meningitis in patients who have not been treated previously or who have relapsed after a previous successful treatment. Cryptococcal meningitis is an important cause of disease and death among patients with AIDS. Usually AMB is given either alone or with FLC to patients with this infection, but these treatments are not always effective and both have toxic effects. Animal studies and preliminary studies in humans show that FCZ is active in cryptococcal meningitis and suggest that it may be less toxic than either AMB or FLC.

Clinical Trial Conditions for Fluconazole In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Fluconazole In Dextrose 5% In Plastic Container
Intervention	Trials
HIV Infections	42
Candidiasis	21
Mycoses	19
Meningitis, Cryptococcal	16

Condition MeSH

Condition MeSH for Fluconazole In Dextrose 5% In Plastic Container
Intervention	Trials
Candidiasis	77
HIV Infections	45
Mycoses	44
Infections	31

Clinical Trial Locations for Fluconazole In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Fluconazole In Dextrose 5% In Plastic Container
Location	Trials
United States	766
China	33
Canada	28
Spain	18
Belgium	15

Trials by US State

Trials by US State for Fluconazole In Dextrose 5% In Plastic Container
Location	Trials
California	57
Texas	53
Florida	46
New York	45
Pennsylvania	39

Clinical Trial Progress for Fluconazole In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Fluconazole In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	57
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Fluconazole In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	183
Unknown status	21
Recruiting	20

Clinical Trial Sponsors for Fluconazole In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Fluconazole In Dextrose 5% In Plastic Container
Sponsor	Trials
Pfizer	40
National Institute of Allergy and Infectious Diseases (NIAID)	25
Merck Sharp & Dohme Corp.	7

Sponsor Type

Sponsor Type for Fluconazole In Dextrose 5% In Plastic Container
Sponsor	Trials
Other	212
Industry	161
NIH	46

Fluconazole in Dextrose 5% in Plastic Container: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Fluconazole Prophylaxis in Premature Infants

A significant clinical trial involving fluconazole was conducted to assess its efficacy in preventing invasive candidiasis in premature infants. This randomized, blinded, placebo-controlled trial included 361 premature infants weighing less than 750 grams from 32 neonatal intensive care units (NICUs) in the United States. The infants were randomly assigned to receive either fluconazole or a placebo twice weekly for 42 days.

The results showed that fluconazole significantly reduced the incidence of invasive candidiasis. The fluconazole group had a 3% incidence of invasive candidiasis, compared to 9% in the placebo group, with a treatment difference of -6% (95% CI, -11% to -1%)[1].

Neurodevelopmental Outcomes

The study also evaluated neurodevelopmental outcomes in surviving infants at 18 to 22 months corrected age. There was no significant difference in neurodevelopmental impairment between the fluconazole and placebo groups, indicating that fluconazole prophylaxis did not adversely affect neurodevelopmental outcomes[1].

Updated Labeling

Recent updates to the approved drug label for DIFLUCAN (fluconazole) include details on clinical trial experience when used for invasive Candida infections in premature infants weighing less than 750 grams at birth and in pediatric patients receiving extracorporeal membrane oxygenation. These updates reflect the ongoing evaluation and refinement of fluconazole's use in vulnerable patient populations[3].

Market Analysis

Global Market Size and Growth

The fluconazole preparation market is experiencing rapid growth, driven by several key factors. The global market size is projected to grow from $41.75 billion in 2023 to $78.69 billion by 2028 at a compound annual growth rate (CAGR) of 13.5%[2].

Key Growth Drivers

• Increasing Fungal Infections: The rise in fungal infections, particularly among immunocompromised populations, is a significant driver.
• Generic Drug Market Expansion: The development of generic versions of fluconazole has made the drug more accessible and affordable.
• Advances in Technology: Innovations such as nanotechnology, advanced drug delivery systems, and personalized medicine are enhancing the efficacy and delivery of fluconazole.
• Government Initiatives and Support: Government programs and initiatives aimed at preventive healthcare are also contributing to the market growth[2].

Market Segmentation

The fluconazole preparation market is segmented based on type (capsule, tablet, eye drops, other types), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and application (hospital, clinic, other applications). Online pharmacies are particularly noted for their growing influence on the market[2].

Geographical Distribution

North America was the largest region in the fluconazole preparation market in 2023, but other regions such as Asia-Pacific, Western Europe, and Eastern Europe are also significant. The global distribution reflects the widespread need for antifungal treatments across different demographics[2].

Projections and Future Trends

Antifungal Drugs Market

The broader antifungal drugs market, which includes fluconazole, is expected to grow from $16.61 billion in 2024 to $20.11 billion by 2029 at a CAGR of 3.9%. This growth is driven by increased awareness of fungal infections, the rise of over-the-counter (OTC) antifungal drugs, and strategic activities by market players such as product launches and collaborations[5].

Innovations and New Products

The market is expected to see continued innovation, with new products and formulations being introduced. For example, the launch of advanced bioavailable itraconazole capsules and new azole antifungals like oteseconazole (VIVJOA) for recurrent vulvovaginal candidiasis are set to enhance treatment options and drive market growth[5].

Challenges and Opportunities

While the market is poised for significant growth, challenges such as increasing resistance to antifungal drugs and side effects may hinder adoption. However, these challenges also present opportunities for research and development of new, more effective, and safer antifungal treatments[5].

Key Takeaways

• Clinical Efficacy: Fluconazole has been shown to reduce the incidence of invasive candidiasis in premature infants without adverse neurodevelopmental effects.
• Market Growth: The fluconazole preparation market is projected to grow significantly, driven by increasing fungal infections, generic drug market expansion, and technological advancements.
• Segmentation and Distribution: The market is segmented by type, distribution channel, and application, with online pharmacies playing a growing role.
• Geographical Presence: North America is currently the largest market, but other regions are also significant.
• Future Trends: Innovations in drug delivery and new product launches are expected to continue driving market growth.

FAQs

Q: What is the primary use of fluconazole in clinical settings?

A: Fluconazole is primarily used to treat and prevent fungal infections, including invasive candidiasis, particularly in vulnerable populations such as premature infants and immunocompromised patients.

Q: How does fluconazole prophylaxis affect premature infants?

A: Fluconazole prophylaxis significantly reduces the incidence of invasive candidiasis in premature infants without adversely affecting their neurodevelopmental outcomes.

Q: What are the key drivers of the fluconazole preparation market growth?

A: The key drivers include increasing fungal infections, generic drug market expansion, advances in technology, and government initiatives supporting preventive healthcare.

Q: How is the fluconazole preparation market segmented?

A: The market is segmented by type (capsule, tablet, eye drops, etc.), distribution channel (hospital pharmacies, retail pharmacies, online pharmacies), and application (hospital, clinic, etc.).

Q: What are the future trends in the antifungal drugs market?

A: Future trends include innovations in drug delivery, new product launches, and a growing focus on preventive healthcare and online pharmacies.

Sources

1. Effect of Fluconazole Prophylaxis on Candidiasis and Mortality in Premature Infants: JAMA, May 7, 2014.
2. Global Fluconazole Preparation Market Set For 13.5% Growth, Reaching $78.69 Billion By 2028: EIN Presswire, December 9, 2024.
3. Drug Labeling Updates – February 2024: Coram, February 2024.
4. DIFLUCAN ® TABLET, SUSPENSION Clinical Studies: Pfizer Medical Information.
5. Antifungal Drugs Market Size & Share Analysis - Growth Trends: Mordor Intelligence.