Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients

NCT04725942 | Completed FDA Drug

• 1 other identifier: NI2020003
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 4

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 infections in patients with hematopoietic stem cell transplantation. The correlation of UGT1A4\*3 genotype and Cmin of Posaconazole, as well as invasive fungal disease (IFD) breakthrough rates will be utilized to evaluate the efficacy while the safety of Posaconazole will be assessed by the overall incidence and severity of adverse events in patients.

Conditions

Pulmonary Fungal Infection

Outcome Measures

Primary Outcomes (1)

• UGT1A4*3 genotype and plasma concentration of posaconazole

  Blood samples were drawn at baseline (day 0) for analysis of patients' UGT1A4\*3 genotypes and assigned to homozygous, wild-type, and heterozygous genotypes. For posaconazole serum concentrations, blood samples were collected at day 0, 4, 8, 15 and 22.

  From day 0 to day 22

Secondary Outcomes (9)

• The incidence of invasive fungal disease (IFD) and the incidence of Aspergillus infection

  90 days posaconazole prophylaxis and 7 days after prophylaxis ending

• Plasma concentration of the patients who received different dosages of posaconazole as prophylaxis at different time points

  Day 0, 4, 8, 15 and 22

• The influence of other combined medications for posaconazole plasma concentrations

  Duration of 90-day posaconazole prophylaxis

• Effect of GVHD grading on absorption and utilization of posaconazole tablets (plasma concentration)

  Duration of 90-day posaconazole prophylaxis

• Effect of diarrhea on absorption and utilization of posaconazole tablets (plasma concentration)

  Duration of 90-day posaconazole prophylaxis

Interventions

Oral Posaconazole tablets DRUG

Posaconazole tablets (300 mg Q12h D1) taken orally on the day of transplantation, and followed by 300mg Qd, until 90 days after transplantation.

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hematopoietic stem cell transplant patients treated with Posaconazole tablets

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Shanxi Bethune Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (4)

The Second Hospital of Hebei Medical University

Shijia Zhuang, China

Location

Shanxi Bethune Hospital

Taiyuan, China

Location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Lung Diseases, Fungal

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 27, 2021
• Study Start: February 8, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 11, 2026

Record last verified: 2022-08

Locations

CN (4)