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.
- Conditions
- Treatment of Candidemia and other invasive Candida infectionsMedDRA version: 8.1Level: LLTClassification code 10060573Term: Candidemia
- Registration Number
- EUCTR2006-003951-18-NL
- Lead Sponsor
- Basilea Pharmaceutica Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 526
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 (amenorrhea 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 is using a highly effective method of birth control throughout the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.
5. Patients with candidemia or with an invasive candida infection who have a positive blood or tissue culture obtained within 96 hours prior to randomization, accompanied by related clinical signs and symptoms or histological or cytological changes. Final culture results may still be pending at randomization.
6. Presence of fever (on one occasion > 38°C oral, or equivalent) or hypotension (SBP < 100 mmHg or a decrease in SBP of at least 30 mmHg) or appropriate local signs within 96 hours prior to randomization.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Women who are pregnant or breastfeeding
2. Known history of allergy, hypersensitivity, or any serious reaction to any of the azole or echinocandin class of antifungal or to any component of the study medication.
3. Patients for whom CAS or VRC is contra-indicated.
4. Patients at high risk for QT/QTc prolongation e.g.
- a family history of long QT syndrome
or
- other known pro-arrhythmic conditions.
5. Evidence of moderate to severe hepatic or renal dysfunction with any of the following abnormalities at screening:
- Total bilirubin = 3 x upper limit of normal (ULN)
- Alanine transaminase or aspartate transaminase = 5 x ULN
- Child-Pugh score > 6
- Calculated creatinine clearance < 10 mL/minute.
6. Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine in the 5 days prior to first administration of study medication.
7. Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens.
8. Patients with candidemia who failed a previous antifungal therapy for the same infection.
9. Patients with any invasive fungal infection other than candida spp., e.g., cryptococcosis, mould infection or endemic fungal infection.
10. Microbiological findings (e.g. bacterial infection) or other potential conditions that are temporally related and suggest an alternative etiology of the clinical features.
11. Patients who have received systemic antifungal therapy (i.e. a cumulative dose greater than any of the following: 0.5 mg/kg amphotericin B; 3 mg/kg liposomal AMB; 800 mg fluconazole; 12 mg/kg VRC; 400 mg itraconazole, 70 mg CAS, 150 mg micafungin, 200 mg anidulafungin, 800 mg posaconazole), for more than 48 hours within 96 hours prior to the first administration of study medication.
12. Severe prolonged immunosuppression (e.g. chronic granulomatous disease, severe combined immunodeficiency, advanced human immunodeficiency virus infection with CD4 count < 200 or acquired immunodeficiency syndrome-defining condition, severe graft versus host disease [grade III-IV associated with e.g., failure of initial treatment, increased liver enzymes or hypoalbuminaemia]), or any other concomitant medical condition that may impede the accurate assessment of efficacy of study drug treatment.
13. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements such as neutropenia not expected to resolve, patients with endocarditis, osteomyelitis, meningitis, uncontrolled malignancy with life expectancy of < 30 days.
14. 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 participates in the study.
15. Patients previously enrolled in a phase III study with isavuconazole.
16. Treatment with any investigational drug in any clinical trial within 30 days prior to the first administration of study medication except unblinded phase III trials.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method