A clinical trial to study the effects of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections.
- Conditions
- Health Condition 1: null- Candidemia and other invasive Candida infections
- Registration Number
- CTRI/2012/01/002351
- Lead Sponsor
- Astellas Pharma Global Development Inc APGD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- 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. HIPAA authorization for US sites or equivalent privacy language as per national regulations must be obtained.
2.Ability and willingness to comply with the protocol.
3.Male and female patients aged >= 18 years at the time of signing informed consent.
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 gonadotropin (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 if histology/cytology reveals yeast.
6.Presence of fever (on one occasion > 38°C oral, or equivalent) or hypothermia (on one occasion < 36°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.
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 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 for unblinded phase III trials.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response at Follow Up 1 (FU1) Visit (2 weeks after EOT)Timepoint: 2 weeks after EOT
- Secondary Outcome Measures
Name Time Method -Overall response at Day 7, EOT and FU2 (6 weeks after EOT) <br/ ><br>-Mycological response at Day 7, EOT, FU1 and FU2 (6 weeks after EOT) <br/ ><br>-Clinical response at Day 7, EOT, FU1 and FU2 <br/ ><br>-Time to first confirmed negative culture <br/ ><br>-All-cause mortality at Day 14, EOT and all FU VisitsTimepoint: Day 7, Day 14, 6 weeks after EOT