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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT03511820
Eligibility Criteria:
Inclusion Criteria:
1. Female or male with no age limit
2. Patient for whom Lipo-AB® is medically recommended due to following conditions:
* Absolute neutrophil count (ANC) \< 500/mm3 for at least 96 hours
* Received parenteral broad spectrum antibacterial therapy for at least 96 hours
* Fever of ≥ 38.0°C (tympanic temperature)
3. Subject or his/her legally acceptable representative is willing and able to provide a written informed consent
Exclusion Criteria:
1. Pregnant female, with the exception of those for whom the possible benefits to be derived outweigh the potential risks involved
2. Use of other investigational product 2 weeks before the initiation of Lipo-AB® treatment which is considered not suitable for this study by investigator
3. Use of any parenteral antifungals for current infection which is not considered treatment failure (either intolerance to the drug or lack of response)
4. Any condition which is considered not suitable for liposomal amphotericin B therapy by investigator
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03511820
Study Brief:
Protocol Section:
NCT03511820