Completed

Fluconazole vs Ketoconazole for Esophageal Candidiasis in Immunocompromised Patients

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What is being tested

Ketoconazole

+ Fluconazole

Drug
Who is being recruted

Blood-Borne Infections+26

+ Urogenital Diseases

+ Genital Diseases

From 13 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on comparing two medications, fluconazole and ketoconazole, in the treatment of a condition called candidal esophagitis, which is an infection in the esophagus caused by a type of fungus called candida. The study involves immunocompromised patients, or individuals with weakened immune systems, who are more susceptible to such infections. The main goal is to find out which of these two medications works better and is safer for these patients, potentially improving their care and addressing the challenges posed by this condition. During the study, participants receive either fluconazole or ketoconazole as their treatment. The study then measures and compares the safety, tolerance, and effectiveness of these two medications. This involves evaluating how well each medication fights the infection, how well each is tolerated by the patients, and any potential side effects that may occur. The findings of this study could help determine the best treatment approach for candidal esophagitis in immunocompromised patients.

Principal SponsorPfizer
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 13 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCommunicable DiseasesDigestive System DiseasesEsophageal DiseasesGastroenteritisGastrointestinal DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsStomatognathic DiseasesMouth DiseasesMycosesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCandidiasisCandidiasis, OralEsophagitisHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

2 inclusion criteria required to participate
Allowed: Cyclosporin if levels can be monitored for proper cyclosporin dose adjustment

Patients must meet the CDC criteria for the diagnosis of AIDS or be otherwise immunocompromised (e.g., malignancy, renal transplant) and have a diagnosis of oral candidiasis and/or esophageal symptoms of dysphagia and/or odynophagia

17 exclusion criteria prevent from participating
Abnormalities which may preclude esophagoscopy or endoscopy before or during the study

Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment

Evidence of noncandidal systemic fungal infections

History of allergy to imidazoles

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 42 locations

Good Samaritan Med Ctr

Phoenix, United StatesOpen Good Samaritan Med Ctr in Google Maps

Arkansas Children's Hosp

Little Rock, United States

Los Angeles County - USC Med Ctr

Los Angeles, United States

Eisenhower Med Ctr

Rancho Mirage, United States
Completed42 Study Centers