An Individualized Administration Research of Voriconazole Based on CYP2C19 Gene Polymorphism and TDM
NCT ID: NCT04004078
Last Updated: 2022-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
314 participants
OBSERVATIONAL
2018-03-01
2021-05-01
Brief Summary
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Detailed Description
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Patients were excluded who fulfilled any of the following criteria:(1) patients who are allergic to voriconazole or have poor compliance, (2) use other antifungal drugs during the use of VCZ, (3) do not qualify for blood sampling monitored by blood concentration, (4) patients with severe liver function impairment (ALT and AST before VCZ treatment are greater than 5 times the normal upper limit, TBIL is greater than 3 times the normal upper limit), 5) pregnant or lactating women, (6) with incomplete clinical data collection, (7) have participated in other clinical trials in the past three months.
Grouping: 1) The patients were grouped according to CYP2C19 gene detection, they were divided into gene-directed group and non-gene-directed group; 2) According to the effect of treatment, the patients were divided into effective group and ineffective group; 3) According to whether patients had adverse reactions, they were divided into group A (adverse reactions) and group B (no adverse reactions). The clinical indicators and detection values of each group were recorded, respectively.
Loading Dosage of administration and treatment regimen : All the selected patients were treated with VCZ. Dose of administration is shown for gene-directed group and non-gene-directed group below. The maintenance dosage was increased or decreased appropriately up to target Cmin range (0.5μg/ml\~5.0μg/ml).
According to CYP2C19 gene detection, phenotypes were classified as ultrarapid metabolisers(UMs)，extensive metabolisers(EMs) ，intermediate metabolisers(IMs) and poor metabolisers(PMs).
Dose of administration and treatment regimen according to CYP2C19 gene detection:(1)Non- gene directed group：Voriconazole was intravenously administered 2 times at the loading dose of 6mg/Kg at 12h intervals , followed by maintenance dosing 4mg/Kg at 12h intervals . Voriconazole was oral administered 2 times at the loading dose of 400mg or 200mg（weight\>40Kg or \<40Kg）at 12h intervals , followed by maintenance dosing 200mg or 100mg（weight\>40Kg or \<40Kg）. Voriconazole was sequential therapy administered 2 times at the loading dose of 6mg/Kg at 12h intervals , followed by maintenance dosing 200mg or 100mg（weight\>40Kg or \<40Kg）. (2) Gene directed group: The dosage of the drug was the same as that of the non-gene-directed group for patients with UMs，EMs and IMs. For the patients with PMs，Voriconazole was intravenously administered 2 times at the loading dose of 4mg/Kg at 12h intervals , followed by maintenance dosing 3mg/Kg at 12h intervals . Voriconazole was oral administered 2 times at the loading dose of 200mg or 100mg（weight\>40Kg or \<40Kg） at 12h intervals , followed by maintenance dosing 100mg . Voriconazole was sequential therapy administered 2 times at the loading dose of 4mg/Kg at 12h intervals , followed by maintenance dosing 100mg.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group A
Non-gene directed group：Voriconazole was intravenously administered 2 times at the loading dose of 6mg/Kg at 12h intervals , followed by maintenance dosing 4mg/Kg at 12h intervals . Voriconazole was oral administered 2 times at the loading dose of 400mg or 200mg（weight\>40Kg or \<40Kg）at 12h intervals , followed by maintenance dosing 200mg or 100mg（weight\>40Kg or \<40Kg）. Voriconazole was sequential therapy administered 2 times at the loading dose of 6mg/Kg at 12h intervals , followed by maintenance dosing 200mg or 100mg（weight\>40Kg or \<40Kg）.
other antifungal agents,breathing machine
If treatment failure for patients in group A，group B，group C and group D，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.
Group B
Gene directed group（UMs and EMs）：The dosage of the drug was the same as that of the non-gene-directed group for patients with UMs，EMs.
other antifungal agents,breathing machine
If treatment failure for patients in group A，group B，group C and group D，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.
Group C
Gene directed group（IMs）：The dosage of the drug was the same as that of the non-gene-directed group for patients with IMs.
other antifungal agents,breathing machine
If treatment failure for patients in group A，group B，group C and group D，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.
Group D
Gene directed group（PMs）： Voriconazole was intravenously administered 2 times at the loading dose of 4mg/Kg at 12h intervals , followed by maintenance dosing 3mg/Kg at 12h intervals . Voriconazole was oral administered 2 times at the loading dose of 200mg or 100mg（weight\>40Kg or \<40Kg）at 12h intervals , followed by maintenance dosing 100mg . Voriconazole was sequential therapy administered 2 times at the loading dose of 4mg/Kg at 12h intervals , followed by maintenance dosing 100mg.
other antifungal agents,breathing machine
If treatment failure for patients in group A，group B，group C and group D，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.
Interventions
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other antifungal agents,breathing machine
If treatment failure for patients in group A，group B，group C and group D，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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of invasive fungal infection
* written informed consent was obtained from each patients
* At least one steady trough concentration blood sample was taken from each patient
Exclusion Criteria
* use other antifungal drugs during the use of VCZ
* do not qualify for blood sampling monitored by blood concentration
* patients with severe liver function impairment (ALT and AST before VCZ treatment are greater than 5 times the normal upper limit, TBIL is greater than 3 times the normal upper limit)
* pregnant or lactating women,
* with incomplete clinical data collection
* have participated in other clinical trials in the past three months
18 Years
ALL
No
Sponsors
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People's Hospital of Zhengzhou University
OTHER
Responsible Party
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LIjuan Zhou
Principal Investigator
Locations
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Zhengzhou Central Hospital affiliated to Zhengzhou University
Zhengzhou, Henan, China
Countries
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Other Identifiers
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zhou750423
Identifier Type: -
Identifier Source: org_study_id
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