Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00509834
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained before admission in the study.
* Patients in whom Candida species have been confirmed by 2 consecutive blood cultures within 12 hours.
* Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 hours prior to entry.
* Patients who have hepatic and renal parameters within 2X ULN (upper level of normality) at screening.
Exclusion Criteria:
* Patients with a history of hypersensitivity to fluconazole or hLF1-11.
* Patients who have been treated with fluconazole for at least 1 week within the previous 4 weeks.
* Patients with a history of fluconazole-resistant Candida species within 12 weeks.
* Neutropenic patients with neutrophil count below 0.5x10\^9/L.
* Patients who are treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
* Patients known to have AIDS or who are HIV-positive.
* Females who have a positive pregnancy test at baseline or are capable of child-bearing i.e. without appropriate contraception (chemical or mechanical).
* Patients with suspected candida osteomyelitis, endocarditis, or meningitis.
* Patients who have received an investigational drug within three months prior to the study.
* Patients with a concomitant medical condition, in whom, in the opinion of the Investigator, participation may create an unacceptable risk for the patient.
* Patients considered inappropriate by the PI for enrollment in the study, for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00509834
Study Brief:
Protocol Section:
NCT00509834