Clinical Trials Logo
  1. Home
  2. Invasive Fungal Infections
  3. NCT03572049

Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole — MSG15  

Invasive Fungal Infections Clinical Trial

Official title:
SUBA-itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses: a Multi-center, Open-label Comparative Trial

Clinical Trial Summary

This is a prospective, multi-center, randomized, open-label parallel arm study involving patients with proven or probable invasive endemic fungal infection to ascertain the pharmacokinetics, safety, efficacy, tolerability and health economics of oral SUBA-itraconazole compared to conventional itraconazole. Patients will receive randomized open-label study drug (SUBA-itraconazole or conventional itraconazole) over a 42 day period and then continue therapy until Day 180. Patients will be stratified based on clinically reported infection with the human immunodeficiency virus (HIV).

Clinical Trial Description

This is a prospective, multi-center, randomized, open-label parallel arm study involving patients with proven or probable invasive endemic fungal infection to ascertain the pharmacokinetics, safety, efficacy, and tolerability of oral SUBA-itraconazole or itraconazole. Patients will receive randomized open-label study drug (either SUBA- itraconazole 130 mg twice daily or itraconazole 200 mg twice daily) over a 42-day period and then continue on their assigned open-label therapy until day 180. The study sample size will be 80 evaluable patients - target enrollment (three arms: approximately 40 histoplasmosis, 20 coccidioidomycosis, 20 other endemic fungal infections). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03572049
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 17, 2018
Completion date April 29, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT05749380 - Pharmacokinetics and Safety of AmBisome and DKF-5122 Phase 1
Not yet recruiting NCT02527928 - Cost-Effectiveness of Amphotericin B N/A
Completed NCT02851680 - Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia. N/A
Suspended NCT05534529 - Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age Phase 1
Completed NCT04024995 - Revision of Antifungal Strategies Definitions for Invasive Fungal Infections in Hematological Malignancies
Completed NCT00745992 - Voriconazole Blood Level and Liver Metabolizing Enzyme in Taiwanese Patients
Completed NCT06413056 - Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection Phase 4
Recruiting NCT05130723 - Pharmacokinetics of Fluconazole in Children (2-18 Years)
Recruiting NCT04157465 - Anti-fungal Strategies in Acute-on-Chronic Liver Failure Patients N/A
Completed NCT04122560 - Fluconazole Pharmacokinetics, Including Bioavailability, in Obese Subjects After an Intravenous and Oral Administration Phase 4
Completed NCT03262584 - Evaluation of NGS for Detection and Follow-up of Fungal Pathogens in Immunocompromised Pediatric Patients
Completed NCT02678598 - A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections N/A
Completed NCT05491733 - A Bioequivalence Study of APX001 High-load and Low-load Tablets Phase 1
Not yet recruiting NCT06220370 - PATH Study: People With Injecting Related Infections: Assessing Treatment Outcomes for Those Who Are Hospitalised.
Completed NCT04777058 - Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
Recruiting NCT03583164 - Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options Phase 2
Completed NCT03174457 - Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Completed NCT00750737 - Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) Phase 3
Not yet recruiting NCT06346951 - Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS)
Recruiting NCT05750706 - Prospective Observational Study on Incidence of Invasive Fungal Infections Among Patients With Acute Lymphoblastic Leukemia Ph-negative