Phase 3
Completed N=88
Endemic Mycoses Treatment With SUBA-itraconazole vs Itraconazole
Source: ClinicalTrials.gov NCT03572049 ↗Enrolled (actual)
88
Serious AEs
18.2%
Results posted
Oct 2022
Primary outcomePrimary: Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14 — 60.5; 71.0 percentage of participants
◆ Published Evidence
Established
39citations · ~7 / year
Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults.
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).
Linked Publications (2)
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Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults.
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MSG-15: Super-Bioavailability Itraconazole Versus Conventional Itraconazole in the Treatment of Endemic Mycoses-A Multicenter, Open-Label, Randomized Comparative Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 14 |
60.5; 71.0 | — |
| PRIMARY Frequency of Treatment Related Adverse Events Days 1-42 |
15; 27 | — |
| SECONDARY Comparison of Plasma Itraconazole Levels and Hydroxyitraconazole Levels at Day 42 |
69.3; 58.0 | — |
| SECONDARY Resolution of Signs and Symptoms of Invasive Fungal Infection on Day 42 |
29; 30 | — |
| SECONDARY The Number of Days of Hospitalization at Day 180 |
5; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients age > 18 years who have given written informed consent to participate
- Patients with a proven or probable endemic mycosis (Histoplasma, Coccidioides, Paracoccidioides, Blastomyces, Sporothrix, Talaromyces marneffei (formerly Penicillium marneffei) according to current EORTC/MSG (Mycoses Study Group) criteria, including patients who:
- Are immunosuppressed, including as a result of HIV/AIDS
- Have had a heart, lung or bone marrow transplant
- Have had chemotherapy for cancer
- Are otherwise normal hosts
Exclusion Criteria
- Significant liver dysfunction as evidenced by at least 5 times greater than upper limits of normal baseline ALT (alanine aminotransferase) , AST (aspartate aminotransferase), alkaline phosphatase, or total bilirubin.
- Use of an alternative antifungal therapy (IV or oral) for more than 14 days for this infection, with the exception of Coccidioidomycosis. Subjects with Coccidioidomycosis who previously received fluconazole therapy for more than 14 days may be included, if in the opinion of the investigator, they are having an inadequate response or, are intolerant of fluconazole (e.g. due to adverse events). Such subjects must washout from fluconazole for 7 days (~5 half-lives of fluconazole) before starting investigational therapy.
- Evidence of CNS (central nervous system) infection.
- Unable to take PO medications.
- Female patients who are lactating or pregnant.
Women should be:
- Postmenopausal for 1 year,
- Post-hysterectomy or bilateral oophorectomy,
- If of child bearing potential have a negative β-HCG (human chorionic gonadotropin) at screening and using highly effective method of birth control throughout course of study or remain abstinent for duration of study.
- Documented intolerance, allergy or hypersensitivity to an azole.
- Inability to comply with study treatment, study visits, and study procedures.
- Known history of congestive cardiac failure on medical treatment, fungal endocarditis, or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole.
- Patients with active TB (tuberculosis)
- Concurrent use of astemizole, rifampin/rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine, terfenadine, ketoconazole, valproic acid, or St. John's wort in the 5 days prior to first administration of study drug.
- Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy.
- Treatment with any investigational agent in the 30 days prior to study entry.
- Patients unlikely to survive 30 days (including severe fungal disease defined by systolic blood pressure (SBP) < 90; hypoxia < 60).
- Patients with body weight < 40 kg.
Data sourced from ClinicalTrials.gov (NCT03572049) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.