MedPath

Fluconazole

Generic Name
Fluconazole
Brand Names
Diflucan
Drug Type
Small Molecule
Chemical Formula
C13H12F2N6O
CAS Number
86386-73-4
Unique Ingredient Identifier
8VZV102JFY
Background

Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose.

Indication

Fluconazole can be administered in the treatment of the following fungal infections:

1) Vaginal yeast infections caused by Candida

2) Systemic Candida infections

3) Both esophageal and oropharyngeal candidiasis

4) Cryptococcal meningitis

5) UTI (urinary tract infection) by Candida

6) Peritonitis (inflammation of the peritoneum) caused by Candida

A note on fungal infection prophylaxis

Patients receiving bone marrow transplantation who are treated with cytotoxic chemotherapy and/or radiation therapy may be predisposed to candida infections, and may receive fluconazole as prophylactic therapy.

A note on laboratory testing

Obtaining specimens for fungal culture and other important laboratory studies such as serology or pathology is advised before starting fluconazole therapy in order to isolate the organisms to be eliminated through treatment. It is permissible to start therapy before the results are available, however, adjusting the therapy once laboratory results confirm the causative organism may be necessary.

Associated Conditions
Candida intertrigo, Candida pneumonia, Candida urinary tract infection, Candidemia, Candidiasis, Coccidioidomycosis, Esophageal Candidiasis, Fungal Infections, Fungal peritonitis caused by Candida, Meningitis, Cryptococcal, Oropharyngeal Candidiasis, Peritoneal candidiasis, Pneumonia cryptococcal, Pruritus, Skin Irritation, Systemic Candida Infections caused by Candida, Vaginal Candidiasis, Disseminated Candidiasis

Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration

Phase 4
Completed
Conditions
Fluconazole
Candidiasis
Obesity
Invasive Fungal Infections
Interventions
First Posted Date
2019-10-10
Last Posted Date
2021-07-14
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
25
Registration Number
NCT04122560
Locations
🇳🇱

St. Antonius hospital, Nieuwegein, Netherlands

🇳🇱

Radboudumc, Nijmegen, Netherlands

Single Dose Crossover Comparative Bioavailability Study of Two Formulations of Fluconazole 200 mg in Healthy Adult Subjects Under Fasting Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2019-07-30
Last Posted Date
2023-11-30
Lead Sponsor
Pharmtechnology LLC
Target Recruit Count
26
Registration Number
NCT04038008
Locations
🇨🇦

Altasciences Company Inc., Mont-Royal, Quebec, Canada

Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

Phase 3
Completed
Conditions
Recurrent Vulvovaginal Candidiasis
Interventions
First Posted Date
2019-07-23
Last Posted Date
2023-06-18
Lead Sponsor
Scynexis, Inc.
Target Recruit Count
440
Registration Number
NCT04029116
Locations
🇺🇸

Chattanooga Medical Research Inc, Chattanooga, Tennessee, United States

🇺🇸

Clinical Research Prime - ClinEdge - PPDS, Idaho Falls, Idaho, United States

🇺🇸

Women's Healthcare Research Corp, San Diego, California, United States

and more 22 locations

Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia

Phase 2
Recruiting
Conditions
Cryptococcal Meningitis
Interventions
Drug: Single dose liposomal Amphotericin and Fluconazole
First Posted Date
2019-05-10
Last Posted Date
2023-04-12
Lead Sponsor
Makerere University
Target Recruit Count
356
Registration Number
NCT03945448
Locations
🇺🇬

infectious Disease Institute Kampala,Uganda, Kampala, Uganda

A Drug Interaction Study of LY3154207 in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
Drug: LY3154207 Tablet
Drug: LY3154207 Capsule
First Posted Date
2019-05-08
Last Posted Date
2020-01-18
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
36
Registration Number
NCT03942029
Locations
🇺🇸

Covance Clinical Research Inc, Daytona Beach, Florida, United States

The Effects of Gut Micribiota Disruption on the Immune Response After Open Heart Surgery

Not Applicable
Conditions
Systemic Inflammatory Response Syndrome
Postoperative Shock
Coronary Artery Disease
Extracorporeal Circulation; Complications
Interventions
First Posted Date
2019-05-06
Last Posted Date
2021-03-12
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
80
Registration Number
NCT03939273
Locations
🇳🇱

Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands

Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations

First Posted Date
2019-04-29
Last Posted Date
2019-04-29
Lead Sponsor
Bayer
Target Recruit Count
26
Registration Number
NCT03929861

Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

Phase 3
Completed
Conditions
Recurrent Vulvovaginal Candidiasis
Interventions
First Posted Date
2019-02-15
Last Posted Date
2022-02-04
Lead Sponsor
Mycovia Pharmaceuticals Inc.
Target Recruit Count
219
Registration Number
NCT03840616
Locations
🇺🇸

27, Idaho Falls, Idaho, United States

🇺🇸

36, Miami, Florida, United States

🇺🇸

62, Chicago, Illinois, United States

and more 30 locations

PTX3-targeted Antifungal Prophylaxis

Not Applicable
Recruiting
Conditions
Genetic Predisposition
Fungal Infection
Candidiasis
Acute Myeloid Leukemia
Aspergillosis
Interventions
First Posted Date
2019-02-04
Last Posted Date
2024-02-14
Lead Sponsor
Bochud Pierre-Yves
Target Recruit Count
320
Registration Number
NCT03828773
Locations
🇫🇷

Henri Mondor Hospital, Créteil, Ile De France, France

🇧🇪

University Hospital Leuven (UZ Leuven), Leuven, Belgium

🇧🇪

AZ Sint-Jan Hospital, Bruges, Belgium

and more 6 locations

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

Phase 3
Completed
Conditions
Candidemia
Fungal Infection
Invasive Candidiases
Mycoses
Interventions
Drug: oral placebo
Drug: intravenous placebo
First Posted Date
2018-09-12
Last Posted Date
2023-01-06
Lead Sponsor
Cidara Therapeutics Inc.
Target Recruit Count
199
Registration Number
NCT03667690
Locations
🇮🇱

Chaim Sheba Medical Center, Tel Hashomer, Israel

🇪🇸

Hospital Clinic of Barcelona, Barcelona, Spain

🇮🇹

University Polyclinic Foundation Agostino Gemelli - IRCCS, Rome, Italy

and more 129 locations
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