Invasive Candidiasis MedDRA version: 19.0 Level: LLT Classification code 10064954 Term: Invasive candidiasis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: CANCIDAS
Product Name: caspofungin acetate
Product Code: MK-0991
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is =3 months (=90 days) of age at the time of informed consent. 2. Patient has Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces (e.g., vagina or other genitalia, colonic tract, skin folds, nail beds, etc.). 3. Patient has evidence of infection limited to a positive culture for Candida spp. From the sputum, broncho-alveolar lavage (BAL), catheter tip, or previously placed indwelling non-vascular catheters/drains. 4. Patient has a prosthetic device (e.g., prosthetic heart valve) at a suspected site of Candida infection. 5. Patient is actively co-infected with a non-Candida fungal organism. 6. Patient has received more than 48 hours of systemic (IV or oral) antifungal treatment since the time the positive Candida index culture was collected as therapy for this episode of invasive candidiasis. 7. Patient has failed prior systemic (IV or oral) antifungal therapy for this episode of invasive candidiasis. 8. Patient has exclusionary laboratory values (obtained within 48 hours of study therapy initiation) as listed below: •?Aspartate aminotransferase (AST, also referred to as SGOT) >3 times the upper limit of normal, for age. •?Alanine aminotransferase (ALT, also referred to as SGPT) >3 times the upper limit of normal, for age. 9. Patient is not expected to survive at least 5 days. 10. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause. 11. Patient is currently participating or has participated in a study with an investigational compound or device. 12. Patient has previously participated in this study. 13. Patient is scheduled or anticipated to receive rifampin or other systemic (IV or oral) antifungal therapy (i.e., an intravenous or oral formulation of the member of the polyene, triazole, or echinocandin class) while on study therapy. 14. Patient has known renal insufficiency, which, in the investigator's assessment, has the potential to worsen as a result of subsequent study therapy with amphotericin B deoxycholate. 15. Patient or the patient’s mother has a history of allergy, hypersensitivity, or any serious reaction to caspofungin or another member of the echinocandin class (e.g., micafungin, anidulafungin, or aminocandin). 16. Patient or the patient’s mother has a history of allergy, hypersensitivity, or any serious reaction to amphotericin B deoxycholate or other members of the polyene class (e.g., amphotericin B lipid complex, liposomal amphotericin B, or amphotericin B colloidal dispersion). 17. Patient has a severe congenital disorder known to lower immune response. 18. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2 weeks following the completion of study therapy; Main Objective: Objective: To compare caspofungin to amphotericin B deoxycholate with respect to the efficacy endpoint of fungal-free survival at the 2-week post-therapy follow-up visit (i.e., the proportion of patients who survived through the 2-week post-therapy follow-up period and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy). ; Secondary Objective: Efficacy: To assess in neonates and infants who are treated with caspofungin or amphotericin B deoxycholate for documented invasive candidiasis, fungal-free survival at the end of study therapy (i.e., the proportion of patients who survived through the end of study therapy visit period and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy). Safety: To assess the safety in neonates and infants who are treated with caspofungin or amphotericin B deoxycholate for documented invasive candidiasis. ; Primary end point(s): Pharmacokinetic (PK) profile (Cmax [peak], C24 hr [trough]) of the administered dose of caspofungin will be determined for neonates and infants less than three months of age on or around Days 4 and 7 of study therapy. Pharmacokinetic profiling will be the responsibility of the Drug Metabolism department of the SPONSOR (or its designee). The primary efficacy endpoint of interest will be fungal-free survival at two weeks posttherapy. Fungal-free survival is defined as those patients who survived at the time point of interest and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up c | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoint will be fungal-free survival at the end of study therapy. In addition, there will be two exploratory efficacy endpoints: •Fungal-free survival at 2 weeks posttherapy in the subset of patients with Candida meningoencephalitis at study entry •Development of complicated candidiasis while on study therapy or during the 8-week posttherapy follow-up period. Complicated candidiasis is defined as the development of any one of the following on or after Day 5 of study therapy: (a) valvular vegetation or mural thrombus on echocardiogram, (b) meningitis documented by the presence of Candida in CSF culture or a CSF WBC count >25 cells/mm3 with no other organism identified, (c) evidence of abdominal abscess, or (d) documented endophthalmitis. Safety: To address the secondary safety objective, the following safety endpoints will be evaluated: (1) the development of adverse experience(s) during the study therapy period or during the 2-week posttherapy follow-up period; (2) the development of drug-related adverse experience(s) during the study therapy period or during the 2-week posttherapy follow-up period; (3) the development of serious adverse experience(s) during study therapy period or during the 2-week posttherapy follow-up period; (4) the development of drug-related, serious adverse experience(s) during study therapy period or during the 2 week posttherapy follow-up period; (5) the development of adverse experiences that necessitate discontinuation of study therapy; and (6) the development of drug-related adverse experiences that necessitate discontinuation of study therapy. ;Timepoint(s) of evaluation of this end point: end of study therapy | — |
Countries
Brazil, Bulgaria, Colombia, Mexico, Romania, South Africa, Turkey, Ukraine, United States
Contacts
Public ContactHedy Teppler
Merck Sharp & Dohme Corp.
Outcome results
None listed