CLINICAL TRIALS PROFILE FOR FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

505(b)(2) Clinical Trials for Fluconazole In Sodium Chloride 0.9%

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.

All Clinical Trials for Fluconazole In Sodium Chloride 0.9%

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.

Clinical Trial Conditions for Fluconazole In Sodium Chloride 0.9%

Condition Name

Condition Name for Fluconazole In Sodium Chloride 0.9%
Intervention	Trials
HIV Infections	42
Candidiasis	21
Mycoses	19

Condition MeSH

Condition MeSH for Fluconazole In Sodium Chloride 0.9%
Intervention	Trials
Candidiasis	77
HIV Infections	45
Mycoses	44

Clinical Trial Locations for Fluconazole In Sodium Chloride 0.9%

Trials by Country

Trials by Country for Fluconazole In Sodium Chloride 0.9%
Location	Trials
United States	766
China	33
Canada	28
Spain	18
Belgium	15

Trials by US State

Trials by US State for Fluconazole In Sodium Chloride 0.9%
Location	Trials
California	57
Texas	53
Florida	46
New York	45
Pennsylvania	39

Clinical Trial Progress for Fluconazole In Sodium Chloride 0.9%

Clinical Trial Phase

Clinical Trial Phase for Fluconazole In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Phase 4	32
Phase 3	57
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Fluconazole In Sodium Chloride 0.9%
Clinical Trial Phase	Trials
Completed	183
Unknown status	21
Recruiting	20

Clinical Trial Sponsors for Fluconazole In Sodium Chloride 0.9%

Sponsor Name

Sponsor Name for Fluconazole In Sodium Chloride 0.9%
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 Sodium Chloride 0.9%
Sponsor	Trials
Other	212
Industry	161
NIH	46

Fluconazole in Sodium Chloride 0.9%: Clinical Trials, Market Analysis, and Projections

Introduction

Fluconazole in Sodium Chloride 0.9% is a sterile solution of the antifungal agent fluconazole, used intravenously to treat various fungal infections. This article provides an update on the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Patient Population and Dosage

Clinical trials for fluconazole in sodium chloride have involved a diverse patient population, including adults and pediatric patients. The dosage and administration are tailored based on the infecting organism, the patient's condition, and the response to therapy. For example, patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis often require maintenance therapy to prevent relapse[1][2][3].

Adverse Reactions

In clinical trials involving over 4,000 patients treated with fluconazole for 7 days or more, 16% experienced adverse events. The most common adverse reactions included nausea (3.7%), headache (1.9%), skin rash (1.8%), vomiting (1.7%), abdominal pain (1.7%), and diarrhea (1.5%). Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% due to laboratory test abnormalities[1][3].

Serious Adverse Events

Serious adverse events, though rare, include exfoliative skin disorders and hepatic necrosis. These events were more frequently observed in patients with serious underlying diseases such as AIDS or malignancies, who were also receiving multiple concomitant medications[1][3].

Pediatric Patients

In pediatric patients aged 1 day to 17 years, 13% experienced treatment-related adverse events, with vomiting, abdominal pain, nausea, and diarrhea being the most common. Treatment was discontinued in 2.6% of pediatric patients due to adverse clinical events and in 1.0% due to laboratory test abnormalities[1][3].

Pharmacokinetics

Adult Patients

In adult patients, fluconazole exhibits dose-proportional pharmacokinetics. The mean plasma elimination half-life is approximately 30 hours, ranging from 20 to 50 hours. Fluconazole concentrations in cerebrospinal fluid are about 80% of the corresponding plasma concentrations, indicating good penetration into the central nervous system[2].

Pediatric Patients

In pediatric patients, the pharmacokinetic parameters vary by age and dose. For example, in patients aged 2 to 60 days, the clearance and half-life are different compared to those in older children. The drug's pharmacokinetics in pediatric patients support its use in this population, though careful dosing adjustments are necessary[2].

Market Analysis

Current Market Position

Fluconazole in Sodium Chloride 0.9% is a well-established antifungal agent, widely used in hospitals and clinical settings. Its efficacy in treating systemic fungal infections, particularly in immunocompromised patients, has solidified its position in the market. The drug is available from multiple manufacturers, including Baxter, which contributes to its widespread availability[1][2].

Competitive Landscape

The antifungal market is competitive, with other agents like micafungin and amphotericin B also being used. However, fluconazole's broad spectrum of activity, ease of administration, and relatively favorable safety profile make it a preferred choice for many clinicians. In comparative trials, fluconazole has shown efficacy similar to or sometimes superior to other antifungal agents[4].

Economic Impact

The economic impact of fluconazole is significant, particularly in the context of hospital-acquired infections and the treatment of immunocompromised patients. By reducing the length of hospital stays and the need for more intensive treatments, fluconazole can help lower healthcare costs. Additionally, its use in prophylaxis for invasive candida infections in premature infants and patients undergoing hematopoietic stem cell transplantation (HSCT) further underscores its economic benefits[3][4].

Market Projections

Future Demand

The demand for fluconazole in sodium chloride is expected to remain strong due to several factors:

• Increasing Prevalence of Fungal Infections: The rise in immunocompromised patients, such as those with HIV/AIDS and cancer, will continue to drive the demand for effective antifungal treatments.
• Advancements in Healthcare: Improvements in healthcare infrastructure and the increasing availability of antifungal therapies in developing countries will also contribute to growing demand.
• Prophylactic Use: The use of fluconazole as a prophylactic agent in high-risk populations, such as premature infants and HSCT recipients, will continue to be a significant market driver[3][4].

Technological and Regulatory Trends

Future trends may include advancements in formulation and delivery systems, such as more stable and convenient packaging, which could enhance patient compliance and reduce healthcare costs. Regulatory approvals for new indications or expanded use in pediatric populations could also expand the market for fluconazole[2].

Competitive Dynamics

The market is likely to see continued competition from other antifungal agents. However, fluconazole's established reputation, broad spectrum of activity, and extensive clinical data will help it maintain a strong market position. Collaborations between pharmaceutical companies and research institutions may lead to new combination therapies or improved dosing regimens, further solidifying fluconazole's place in the antifungal market[4].

Key Takeaways

• Clinical Efficacy: Fluconazole in sodium chloride has demonstrated strong clinical efficacy in treating a range of fungal infections.
• Safety Profile: While generally well-tolerated, fluconazole can cause serious adverse events, particularly in patients with underlying diseases.
• Market Position: The drug is a leading antifungal agent with a strong market presence.
• Future Demand: Increasing prevalence of fungal infections and advancements in healthcare will drive future demand.
• Competitive Landscape: The market will remain competitive, but fluconazole's established reputation and broad spectrum of activity will help it maintain its position.

FAQs

What are the common adverse reactions associated with fluconazole in sodium chloride?

Common adverse reactions include nausea, headache, skin rash, vomiting, abdominal pain, and diarrhea. Serious adverse events, though rare, can include exfoliative skin disorders and hepatic necrosis[1][3].

How does the pharmacokinetics of fluconazole vary between adult and pediatric patients?

In adults, fluconazole exhibits dose-proportional pharmacokinetics with a half-life of approximately 30 hours. In pediatric patients, the pharmacokinetic parameters vary by age and dose, requiring careful dosing adjustments[2].

What is the current market position of fluconazole in sodium chloride?

Fluconazole in sodium chloride is a well-established antifungal agent widely used in hospitals and clinical settings, with a strong market presence due to its efficacy and safety profile[1][2].

What factors will drive the future demand for fluconazole in sodium chloride?

The increasing prevalence of fungal infections, advancements in healthcare, and the use of fluconazole as a prophylactic agent in high-risk populations will drive future demand[3][4].

How does fluconazole compare to other antifungal agents in the market?

Fluconazole has a broad spectrum of activity and is generally well-tolerated, making it a preferred choice over other antifungal agents in many clinical scenarios. However, the market remains competitive with other agents like micafungin and amphotericin B[4].

Sources

1. FLUCONAZOLE IN SODIUM CHLORIDE INJECTION USP - Baxter. Retrieved from https://www.baxter.ca/sites/g/files/ebysai1431/files/2022-10/Fluconazole%20PM_English%20_0.pdf
2. FLUCONAZOLE IN SODIUM CHLORIDE injection, solution - DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b3efaffa-9ef9-4a4f-998e-aa7d2eb61fc9
3. fluconazole injection in sodium chloride Adverse Reactions - Pfizer Medical Information. Retrieved from https://www.pfizermedicalinformation.com/fluconazole/adverse-reactions
4. Micafungin in Sodium Chloride Injection - Baxter PI. Retrieved from https://www.baxterpi.com/pi-pdf/Micafungin%20in%20Sodium%20Chloride%20Injection%20PI%20Sept%202023%2007-19-06-083.pdf