Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections
- Conditions
- -B369 Superficial mycosis, unspecifiedSuperficial mycosis, unspecifiedB369
- Registration Number
- PER-013-99
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Adults (age> 18 years) of both sexes and of any race, or children (age> 13 years) of both sexes and of any race.
• Subjects must have proven or probable invasive fungal infection.
• Subjects must have an invasive fungal infection resistant or refractory to standard antifungal therapies (Appendix B)
• Informed written consent of the patient or legally authorized representative obtained before entering the study.
• Patients who can take the study medication orally.
• Subjects must be willing to respect the dose schedules, visits and mandatory procedures.
• Women of childbearing age, including those taking oral contraceptives, should use a reliable barrier method of contraception during the study.
• Women of childbearing age must have a serum or negative urine pregnancy test within 72 hours prior to the start of! study drug treatment.
• Pregnant or breastfeeding women.
• History of hypersensitivity or susceptibility to antlfungal azoles.
• Concurrent progressive neurological disease (except if it is a consequence of invasive fungal infection).
• Use of medications that interact with azoles and cause life-threatening effects: terfenadine, cisapride, ebastine, upon entering the study or within 24 hours prior to therapy, or astemizole upon entering the study or within the 10 days prior to admission.
• Use of medications that decrease the serum concentration / efficacy of antlfungal azoles: rifampicin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, upon entering the study or within 3 weeks prior to admission.
• Subjects receiving vinca or anthracycline alkaloids upon entering the study or during treatment with SCH 56592.
• Subjects with an ECG with prolongation of the QTc interval> 20% higher than normal.
• Any condition that requires the use of prohibited medications, (see Section 3.4.3.2.)
• Early or concurrent use of systemic antifungal agents (intravenously or orally) during the study period.
• Liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)> 10 times the upper limit of normal.
• Previous participation in this study.
• Subjects that, in the opinion of the Researcher, present clinical conditions or laboratory tests that may hinder the evaluation of the safety and efficacy of SCH 56592.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:a) Complete response: Resolution of all attributable radiographic and bronchoscopic symptoms, signs and abnormalities, if present at the time of incorporation.<br>b) Partial response: Clinically significant improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation.<br>c) Stable disease: Without improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation.<br>d) Failure: Deterioration of attributable clinical or radiographic abnormalities that require alternative antifungal therapy or cause death.<br>Measure:Clinical response of proven or probable invasive fungal infection at the end of the treatment period<br>Timepoints:at the end of the treatment period<br>
- Secondary Outcome Measures
Name Time Method