An observational study in Invasive Fungal Infection, sponsored by People's Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 98 Years. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by People's Hospital of Zhengzhou University · Observational
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Among 29 studies in Invasive Fungal Infections with a site in China — 12 open to participants now, 12 under way, none of them phase 3. Invasive Fungal Infections · China.
Among the 29 studies in Invasive Fungal Infections with a site in China, this one is the 4th largest by planned enrollment of the 17 observational ones that give a count, is one of 5 that started in 2018, is one of 17 observational ones, reaches primary completion later than 0 of the 11 other live ones, and was the 15th registered.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
Browse Invasive Fungal Infections studies →12 of the 29 studies in Invasive Fungal Infections with a site in China are open now. Recruiting first, the newest first:
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 3–17
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 1 mo–18 yrs
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 18–75
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Peking University People's Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 20 Invasive Fungal Infections studies recruiting now, 12 (60%) set no upper age limit and 5 (25%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 98 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 550 is above the median of 125 across 66 observational studies indexed under Invasive Fungal Infections.
Median enrollment 74 across the 12 interventional studies, 120 across the 17 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
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9 of 29 have an industry lead sponsor. The 10 most frequent:
People's Hospital of Zhengzhou University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
People's Hospital of Zhengzhou University has 2 studies filed under Invasive Fungal Infections — fewer than ten, so there is no comparison to draw.
4 of the studies in Invasive Fungal Infections with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07135778Institute of Hematology & Blood Diseases Hospital, ChinaLiposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases | 2026-12-31 |
| NCT07725263Haikou Affiliated Hospital of Central South University Xiangya School of MedicineLow-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children | 2027-02-28 |
| NCT07357038Institute of Hematology & Blood Diseases Hospital, ChinaA Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis | 2027-02-28 |
| NCT07763184Nanfang Hospital, Southern Medical UniversitymNGS for IFD in Patients With Hematological Malignancies | 2027-09-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 29 studies in Invasive Fungal Infections with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This was a prospective clinical study that all voriconazole-treated adult Chinese patients with invasive pulmonary infection admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from July 2018 to June 2023. The initial voriconazole serum trough concentration, Correlation of various factors, and risk prediction factors for voriconazole serum trough concentration and hepatotoxicity were compared between elderly and non-elderly patients.
A prospective observational study was conducted from July 2018 to June 2023 in Zhengzhou Central Hospital Affiliated to Zhengzhou University. This study was carried out in accordance with the following criteria: (1) patients who met the criteria for diagnosis of IFI, (2) age ≥ 18 years, (3) The duration of VCZ treatment course ≥ 7 days.
Patients were excluded who fulfilled any of the following criteria: (1) Patients who allergic to VCZ, (2) use other anti-fungal drugs during the use of VCZ, (3) do not qualify for blood sampling monitored by blood concentration, (4) pregnant or lactating women, (5) patients who haven't completely and accurately efficacy and safety data, (6) patients who are treated with a combination of liver enzyme inducers and inhibitors (carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on),(7) patients who are treated with a combination of Paxlovid or Azvudine.
Grouping: Patients were divided into the elderly group (group A, ≥ 60 years) and the non-elderly group (group B, \< 60 years) according to ages. All the recruited patients were treated with voriconazole. Voriconazole was intravenously administered 2 times at the loading dose of 6 mg/Kg or orally administered 2 times at the loading dose of 400mg at 12h intervals, followed by a maintenance dose of 4 mg/Kg or 200 mg at 12 h intervals.
All voriconazole-treated adult Henan Chinese Han patients with invasive pulmonary infection were admitted to Zhengzhou Central Hospital affiliated to Zhengzhou University from July 2018 to June 2023.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
the elderly group , the age ≥ 60 years
Device: other antifungal agents,breathing machine
the non-elderly group , the age \< 60 years
Device: other antifungal agents,breathing machine
If treatment failure for patients in group A and group B，change other antifungal agents (Amphotericin B for Injection, 25mg, North China Pharmaceutical Co., Ltd or Caspofungin Acetate for lnjection,50mg and 70mg Cancidas®). Mechanical ventilation (EVITA 4, Dräger Medical Equipment (Shanghai) Co.,Ltd) was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of antifungal agents therapy.
Serum voriconazole trough concentrations
If all patients were administrated by loading dose, voriconazole trough samples were taken immediately 30 minutes before voriconazole administration on the Third day. If all patients were not administrated by loading dose, voriconazole trough samples were taken immediately 30 minutes before voriconazole administration on the sixth day. Blood samples for 2-3 mL were collected in blood-collection tubes without any additives and centrifuged at 3500 rpm for 10min. Serum trough concentrations were determined by a high-performance liquid chromatography method as previously described. A initial steady-state trough concentration blood sample was obtained before dose adjustment for all patients. Each patient received at least one steady-state blood sample. The detections were completed in Translational Medicine Center of Zhengzhou Central Hospital affiliated to Zhengzhou University.
Time frame: 0.5 hour before voriconazole administration on the Third or sixth day.
CYP2C19 Genotyping
CYP2C19 genotype was determined from peripheral blood, which was extracted and stored in an EDTA anticoagulant tube. Real-time fluorescence quantitative PCR (ThermoFisher Applied Biosystems 7500 fast PCR) was performed using a Human CYP2C19 gene detection kit (PCR-fluorescence probe method, Wuhan YZY Medical Science and Technology Co., Ltd, China) following the manufacturer's instructions. Genomic DNA was isolated from whole blood using QIAamp DNA blood kits (Qiagen, Hilden, Germany). According to nomenclature by the Clinical Pharmacogenetics Implementation Consortium (CPIC®), the CYP2C19 genotype was classified as ultrarapid metabolizer (\*17/\*17), rapid metabolizer (\*1/\*17), normal metabolizer (\*1/\*1), intermediate metabolizer (\*1/\*2, \*1/\*3, \*2/\*17, \*3/\*17), or poor metabolizer (\*2/\*2, \*2/\*3, \*3/\*3).
Time frame: Unlimited blood drawing time.
The difference of average voriconazole serum trough concentration between group A and group B
The differences were counted between group A and group B by measuring each patient's voriconazole serum trough concentration.
Time frame: From July 2018 to June 2023
Analysis of factors affecting voriconazole serum trough concentration
A multiple linear stepwise regression analysis was performed by using voriconazole serum trough concentration (Y) as the dependent variable, and sex (x1), age (x2), body weight (x3), VCZ route of administration (x4), CYP2C19 phenotype (x5), the average daily dose (x6), PPIs (x7), methylprednisolone (x8), CRP (x9) , PCT (x10), IL-6 (x11), Albumin (x12), ALP (x13), and TBIL (x14) as independent variables. Linear regression analysis reveals the regression equation and independent risk factors affecting voriconazole serum trough concentration.
Time frame: From July 2018 to June 2023
C-reaction protein (CRP)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Alanine aminotransferase (ALT)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Aspartatrtransaminase (AST)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Gamma-glutamyl transferase(GGT)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Alkaline phosphatase (ALP)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Total bilirubin (TBIL)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
procalcitonin(PCT)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: Before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
interleukin- 6(IL-6)
It was completed before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy in Zhengzhou city clinical inspection center.
Time frame: before initiation, On the day of blood sample extraction with serum trough concentration, and completion of voriconazole therapy
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2018 (actual). Primary completion is estimated for Mar 2024, 68 months after the start.
Of 30 observational studies under Invasive Fungal Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's planned 68 months is above that.
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People's Hospital of Zhengzhou University