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NCT Number: NCT04725942

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

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.

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Key information

Conditions

Pulmonary Fungal Infection Bacterial Infections and Mycoses Infections Lung Diseases Lung Diseases, Fungal Mycoses Respiratory Tract Diseases Respiratory Tract Infections

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Hospital of Hebei Medical University, Shijia Zhuang, China

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About this study

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 patients with hematopoietic stem cell transplantation. A total of 360 hematopoietic stem cell transplantation patients receiving Posaconazole tablets are expected to be enrolled. Posaconazole tablets will be taken orally from the day of transplantation (300 mg Q12h D1) followed by 300 mg Qd, until 90 days after transplantation. The total duration of the study is estimated to be 24 months, with each patient participating for an estimated 3 months. The relationships between UGT1A4*3 genotype and drug serum concentration, IFD incidence, Aspergillus infection rate, IFD-related mortality rate, IFD-free survival rate, and overall survival rate will be used to evaluate the effectiveness of Posaconazole tablets in preventing invasive pulmonary fungal infection in patients with hematopoietic stem cell transplantation. Safety of Posaconazole tablet will be validated by the overall incidence and severity of adverse events in patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. UGT1A4*3 genotype and plasma concentration of posaconazole

    Time frame: From day 0 to day 22

    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.

Secondary outcomes

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

    Time frame: 90 days posaconazole prophylaxis and 7 days after prophylaxis ending

    Patients who developed invasive fungal infections, aspergillus infections or death related with IFD infections during posaconazole prophylaxis treatment were recorded in accordance with IFD diagnostic guidelines (Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376).

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

    Time frame: Day 0, 4, 8, 15 and 22

    Blood samples were drawn from patients at day 0, 4, 8, 15, and 22 after receiving posaconazole.

  3. The influence of other combined medications for posaconazole plasma concentrations

    Time frame: Duration of 90-day posaconazole prophylaxis

    Blood samples were drawn at day 0, 4, 8, 15 and 22 after receiving posaconazole, while all combined medications during posaconazole prophylaxis were recorded and IFD cases were monitored during the study period.

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

    Time frame: Duration of 90-day posaconazole prophylaxis

    Gastrointestinal GVHD grades (I-IV) were recorded according to patient symptoms and posaconazole plasma concentrations were measured using blood samples of each patient after receiving posaconazole tablets at day 0, 4, 8, 15 and 22.

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

    Time frame: Duration of 90-day posaconazole prophylaxis

    Diarrhea (acute watery diarrhea, acute hemorrhagic diarrhea, persistent diarrhea, and diarrhea with severe malnutrition) was recorded according to patient symptoms, and posaconazole plasma concentrations were measured using blood samples of each patient after receiving posaconazole tablets at day 0, 4, 8, 15 and 22.

  6. Number/Proportion of patients with immunosuppressive agent application and adjustments

    Time frame: Duration of 90-day posaconazole prophylaxis

    Recording of the number/proportion of patients who received immunosuppressive agents or adjustments of agents.

  7. Measurement and record of neutrophil counts

    Time frame: Duration of 90-day posaconazole prophylaxis

    Measurement of neutrophils in blood samples of patients.

  8. Measurement and record of duration of neutropenia

    Time frame: Duration of 90-day posaconazole prophylaxis

    Measurement of duration of neutropenia in blood samples of patients.

  9. Adverse events

    Time frame: Duration of 90-day posaconazole prophylaxis

    Record of the number, incidence and frequency of adverse events (AE) during the study period and judge whether the AE is drug related, serious, or special interest AE. AE severity is determined according to MedDRA v23.1.

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Shanxi Bethune Hospital
  • The Second Hospital of Hebei Medical University
  • Tianjin Medical University Cancer Institute and Hospital

Registry information

Official study title

Efficacy, Safety and Serum Concentration of Posaconazole Tablets for Prevention of Pulmonary Fungal Infections in Patients With Hematopoietic Stem Cell Transplantation: An Open, Prospective, Observational, Multicenter Cohort Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2021
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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