A phase III, double-blind, randomized study to evaluate the safety and efficacy of BAL8557 versus a Caspofungin followed by Voriconazole regimen in the treatment of candidemia and other invasive Candida infections. Estudio de fase III, doble ciego, aleatorizado para evaluar la seguridad y eficacia de BAL8557 frente a un régimen de caspofungia, seguido de voriconazol, en el tratamiento de la candemia y otras infecciones invasivas causadas por candida

INTERVENTION: Product Name: Water Soluble Azole Product Code: BAL8557 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Isavuconazolium sulfate Current Sponsor code: BAL8557 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 372.6‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Product Name: Water Soluble Azole Product Code: BAL8557 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Isavuconazolium sulfate Current Sponsor code: BAL8557 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 186.3‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Caspofungin Product Name: Cancidas Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CASPOFUNGIN CAS Number: 179463‐17‐3 Current Sponsor code: CAS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use Trade Name: VFEND Product Name: VFEND Pharmaceutical Form: Capsule, hard INN or Proposed INN: VORICONAZOLE CAS Number: 137234629 Current Sponsor code: VRC Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Caspofungin Product Name: Cancidas Pharmaceutical Form: Intravenous infusion INN or Proposed INN: CASPOFUNGIN CAS Number: 179463‐17‐3 Current Sponsor code: CAS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 70‐ Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Treatment of Candidemia and other invasive Candida infections Tratamiento de candidemia y otras infecciones invasivas causadas por Candida ; MedDRA version: 8.1 Level: LLT Classification code 10060573 Term: Candidemia PRIMARY OUTCOME: Main Objective: To compare safety and efficacy of treatment with BAL8557 versus a caspofungin (CAS) ? voriconazole (VRC) regimen in patients with candidemia or other invasive Candida infections Primary end point(s): Patients will remain on therapy until they have reached a treatment end‐point ; Primary; Overall response at follow‐up 1 (FU1) visit (2 weeks after EOT).; Secondary; ‐ Mycological response Day 7, EOT, FU2 (6 weeks after EOT) and FU3 (12 weeks after; EOT) as well as last evaluable visit; ‐ Time to first confirmed negative culture; ‐ All‐cause 14 and 90‐day mortality(for; definition, see Section 5.2) or have received treatment for the maximum period of; 56 days. Secondary Objective: To compare the effects of treatment on:; ‐ Time to first negative blood culture; ‐ All‐cause 14 and 90 day mortality; ‐ To characterize the safety of treatment with BAL8557; ‐ To characterize the pharmacokinetics (PK) of BAL4815 and cleavage product BAL8278 in the relevant patient population. INCLUSION CRITERIA: 1. Patients and/or legally authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent OR patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person. 2. Ability and willingness to comply with the protocol 3. Male and female patients aged = 18 years 4. Female patients must be non‐lactating and at no risk of pregnancy for one of the following reasons ‐ Postmenopausal for at least 1 year ‐ Post‐hysterectomy and/or post‐bilateral ovariectomy ‐ If of childbearing potential, having a negative serum or urine human chorionic gonadotrophin (hCG) pregnancy test at screening and be using a highly effective method of birth control throughout the study. Reliable sexual abstinence throughout the course of the study is acceptable