Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
- Conditions
- Invasive fungal disease caused by Aspergillus species and Candida strains in patients with renal impairment as well as disease caused by rare moulds, yeast or dimorphic fungi.MedDRA version: 14.1Level: HLTClassification code 10003486Term: Aspergillus infectionsSystem Organ Class: 100000004862MedDRA version: 14.1Level: LLTClassification code 10049160Term: CandidaemiaSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2006-005003-33-HU
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 150
1. Patients and/or legal authorized representative(s), if applicable, who have been fully informed and have given voluntary written informed consent and HIPAA Authorization for US sites, or equivalent privacy language as per national regulations 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, and
HIPAA Authorization for US sites, or equivalent privacy language as per national regulations, witnessed in writing by an independent person.
2. Ability and willingness to comply with the protocol.
3. Male and female patients aged = 18 years, at the time of signing the informed consent form.
4. Female patients must be non-lactating and at no risk for pregnancy
5. Patients who fall into one of the following subgroups:
Patients meeting EORTC/MSG definition [Appendix 1] of proven or culture positive probable IFD caused by rare molds, yeasts, or dimorphic fungi (i.e., fungal pathogens other than Aspergillus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment as defined below.
OR
Patients who have proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.
6. Subject agrees not to participate in another interventional study while on treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Women who are pregnant or breastfeeding.
2. Known history of allergy, hypersensitivity, or any serious reaction to the azole class of antifungals or to any component of the study medication.
3. Patients at high risk for QT prolongation
4. Patients with evidence of hepatic dysfunction with any of the
following abnormalities at the time of enrollment:
- Total bilirubin > 3 x upper limit of normal (ULN) OR
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 5 x ULN OR
- Patients with known cirrhosis or chronic hepatic failure
5. Concomitant use of astemizole, cisapride, rifampin/rifampicin,
rifabutin, ergot alkaloids, long acting barbiturates, ritonavir, efavirenz, carbamazepine, pimozide, quinidine, neostigmine,
terfenadine, ketoconazole, valproic acid or St. John's Wort in the 5 days prior to first administration of study medication.
6. Patients with either chronic aspergillosis, aspergilloma or allergic
bronchopulmonary aspergillosis (ABPA).
7. Microbiological findings (e.g. virological) or other potential conditions that are temporally related and suggest a different etiology for the clinical features in the absence of evidence of
systemic fungal infection.
8. Advanced human immunodeficiency virus (HIV) infection with CD4 count < 50 or uncontrolled acquired immunodeficiency syndromedefining condition.
9. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy
10. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study.
11. Patients previously enrolled in a phase III study with ISA.
12. Treatment with any investigational drug in any clinical trial 30 days prior to the first administration of study medication.
13. Patients who are unlikely to survive 30 days.
14. Patients with a body weight < 40 kg.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety and efficacy of isavuconazole in the treatment of invasive aspergillosis in patients with renal impairment or in patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.;Secondary Objective: To determine clinical and mycological response rate by pathogen<br>To evaluate the survival status at Day 42, 84, 120 and 180.;Primary end point(s): The primary efficacy variable is the overall outcome of treatment<br>(clinical, mycological and radiological response) evaluated by DRC at Day 42 by subgroup (e.g. type of pathogen).;Timepoint(s) of evaluation of this end point: Day 42
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Overall outcome of treatment evaluated by Investigator at Day 42 by sub-group<br>? Overall outcome at EOT and Day 84, assessed by DRC and Investigator by sub-group<br>? Clinical response at Days 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group<br>? Mycological response at Day 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group<br>? Survival rate at Day 42, Day 84, Day 120 and Day 180;Timepoint(s) of evaluation of this end point: ? Overall outcome of treatment evaluated by Investigator at Day 42 by sub-group<br>? Overall outcome at EOT and Day 84, assessed by DRC and Investigator by sub-group<br>? Clinical response at Days 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group<br>? Mycological response at Day 42, EOT, Day 84 and FU, assessed by DRC and Investigator by sub-group<br>? Survival rate at Day 42, Day 84, Day 120 and Day 180