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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT00037206
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
* Life expectancy: greater than 72 hours
Exclusion Criteria:
* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
* Aspergilloma-in the absence of invasive disease
* Abnormal blood chemistries:
Bilirubin \> 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)\> 5 times the upper limit of normal
* Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
* Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00037206
Study Brief:
Protocol Section:
NCT00037206