Pulmonary Fungal InfectionNCT04725942
Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients
An observational study of Pulmonary Fungal Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pulmonary Fungal Infection
- What is being tested?
- Oral Posaconazole tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 360 participants
- Where
- 4 sitesChina
- Study dates
- 8 Feb 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hematopoietic stem cell transplant patients treated with Posaconazole tablets
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
The Second Hospital of Hebei Medical University
Shijia Zhuang
Shanxi Bethune Hospital
Taiyuan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin
About this study
Official 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
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.
Read the 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 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.
- Conditions
- Pulmonary Fungal Infection
- Being tested
- Oral Posaconazole tablets
- Medical subject headings
- Lung Diseases, Fungal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Posaconazole tabletsDrug
Posaconazole tablets (300 mg Q12h D1) taken orally on the day of transplantation, and followed by 300mg Qd, until 90 days after transplantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day 0 to day 22
Secondary outcomes (9)
The incidence of invasive fungal disease (IFD) and the incidence of Aspergillus infection
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).
Measured: 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
Blood samples were drawn from patients at day 0, 4, 8, 15, and 22 after receiving posaconazole.
Measured: Day 0, 4, 8, 15 and 22
The influence of other combined medications for posaconazole plasma concentrations
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.
Measured: Duration of 90-day posaconazole prophylaxis
Effect of GVHD grading on absorption and utilization of posaconazole tablets (plasma concentration)
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.
Measured: Duration of 90-day posaconazole prophylaxis
Effect of diarrhea on absorption and utilization of posaconazole tablets (plasma concentration)
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.
Measured: Duration of 90-day posaconazole prophylaxis
Number/Proportion of patients with immunosuppressive agent application and adjustments
Recording of the number/proportion of patients who received immunosuppressive agents or adjustments of agents.
Measured: Duration of 90-day posaconazole prophylaxis
Measurement and record of neutrophil counts
Measurement of neutrophils in blood samples of patients.
Measured: Duration of 90-day posaconazole prophylaxis
Measurement and record of duration of neutropenia
Measurement of duration of neutropenia in blood samples of patients.
Measured: Duration of 90-day posaconazole prophylaxis
Adverse events
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.
Measured: Duration of 90-day posaconazole prophylaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start8 Feb 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Bethune Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725942
- Sponsor's protocol ID
- NI2020003
- Status last verified
- Aug 2022
- First submitted
- 12 Jan 2021
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04725942
- Acronym / sponsor ID
- NI2020003
- Conditions
- Pulmonary Fungal Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shanxi Bethune Hospital, The Second Hospital of Hebei Medical University, Tianjin Medical University Cancer Institute and Hospital
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hematopoietic stem cell transplant patients treated with Posaconazole tablets
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Posaconazole tabletsPosaconazole tablets (300 mg Q12h D1) taken orally on the day of transplantation, and followed by 300mg Qd, until 90 days after transplantation. | Drug | – |
Primary outcome
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.
9 secondary outcomes
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
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
The influence of other combined medications for posaconazole plasma concentrations
Time frame: Duration of 90-day posaconazole prophylaxis
Effect of GVHD grading on absorption and utilization of posaconazole tablets (plasma concentration)
Time frame: Duration of 90-day posaconazole prophylaxis
Effect of diarrhea on absorption and utilization of posaconazole tablets (plasma concentration)
Time frame: Duration of 90-day posaconazole prophylaxis
Number/Proportion of patients with immunosuppressive agent application and adjustments
Time frame: Duration of 90-day posaconazole prophylaxis
Measurement and record of neutrophil counts
Time frame: Duration of 90-day posaconazole prophylaxis
Measurement and record of duration of neutropenia
Time frame: Duration of 90-day posaconazole prophylaxis
Adverse events
Time frame: Duration of 90-day posaconazole prophylaxis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fungal Infection, run by Institute of Hematology & Blood Diseases Hospital, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UGT1A4*3 genotype and plasma concentration of posaconazole (time frame: From day 0 to day 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.