Status:
UNKNOWN
Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Shanxi Bethune Hospital
The Second Hospital of Hebei Medical University
Conditions:
Pulmonary Fungal Infection
Eligibility:
All Genders
13+ years
Brief Summary
This open, prospective, observational multicenter cohort study aims to evaluate the efficacy, safety as well as the effective serum concentration of Posaconazole for prevention of pulmonary fungal inf...
Detailed Description
This open, prospective, observational multicenter cohort study aims to study the efficacy, safety and effective concentration of Posaconazole tablets for prevention of pulmonary fungal infection in pa...
Eligibility Criteria
Inclusion
- Age ≥ 13 years old
- The primary causes of hematopoietic stem cell transplantation include aplastic anemia, acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, or other hematologic diseases in patients pretreated for hematopoietic stem cell transplantation. The types of transplantation include autologous transplantation, syngeneic transplantation, matched sibling donor transplantation, unrelated donor transplantation and haploidentical transplantation
- The patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent
Exclusion
- Those with evidence of active fungal infection within 3 weeks prior to enrollment
- Allergic to azole drugs
- Severe abnormal liver function
- Rifampicin, isoniazid, phenytoin, carbamazepine, and long-acting barbiturates were used in combination during the study
- Any predictably increased patient risk or other factors that might interfere with the outcome of a clinical trial
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04725942
Start Date
January 1 2021
End Date
April 1 2023
Last Update
January 27 2021
Active Locations (4)
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1
The Second Hospital of Hebei Medical University
Shijia Zhuang, China
2
Shanxi Bethune Hospital
Taiyuan, China
3
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
4
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China