None listed
Conditions
Interventions
SCH 56592 Type of group
SCH 56592 200 mg administered orally 4 times a day (QID) while the patient is hospitalized followed by 400 mg of the drug administered orally twice a day or (BID) when the patient is discharged from hospital in the treatment of invasive fungal infections .
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • 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.
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:a) Complete response: Resolution of all attributable radiographic and bronchoscopic symptoms, signs and abnormalities, if present at the time of incorporation. b) Partial response: Clinically significant improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation. c) Stable disease: Without improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation. d) Failure: Deterioration of attributable clinical or radiographic abnormalities that require alternative antifungal therapy or cause death. Measure:Clinical response of proven or probable invasive fungal infection at the end of the treatment period Timepoints:at the end of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:a) Complete response: Resolution of all attributable radiographic and bronchoscopic symptoms, signs and abnormalities, if present at the time of incorporation. b) Partial response: Clinically significant improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation. c) Stable disease: Without improvement of the symptoms, signs and attributable radiographic or bronchoscopic abnormalities, if present at the time of incorporation. d) Failure: Deterioration of attributable clinical or radiographic abnormalities that require alternative antifungal therapy or cause death. Measure:Clinical response 30 days after treatment. Timepoints:30 days after treatment. ; Outcome name:negative culture or histologically documented absence of the infectious fungal pathogen from a primary site that was initially positive, at the end of treatment Measure:Mycological eradication Timepoints:at the end of treatment ; Outcome name:It will be observed if the patient is still alive at the end of therapy. Information about mortality and its causes will be recorded during the treatment period of the study and 30 days after it. Measure:Survival of 30 days after the last day of administration of the study drug. Timepoints:30 days after the last day of administration of the study drug. | — |
Countries
Peru, United States
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed