Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04004078 |
| Other study ID # |
zhou750423 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
People's Hospital of Zhengzhou University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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 March 2018 to April 2020.
Description:
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 March 2018 to April 2020. Patients were included who met the
following criteria:(1)age≥18 years old, (2)Diagnosis of invasive fungal infection,(3)written
informed consent was obtained from each patients,(4)At least one steady trough concentration
blood sample was taken from each patient.
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.
