Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients

People's Hospital of Zhengzhou University

Status

Enrolling

Conditions

Invasive Fungal Infection

Treatments

Device: other antifungal agents,breathing machine

Study type

Observational

Funder types

Other

Identifiers

NCT06137690

LJzhou

Details and patient eligibility

About

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.

Full description

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.

Enrollment

550 estimated patients

Sex

All

Ages

18 to 98 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients who met the criteria for diagnosis of IFI
age ≥ 18 years
The duration of VCZ treatment course ≥ 7 days.

Exclusion criteria

Patients who allergic to VCZ
use other anti-fungal drugs during the use of VCZ
do not qualify for blood sampling monitored by blood concentration
pregnant or lactating women
patients who haven't completely and accurately efficacy and safety data
patients who are treated with a combination of liver enzyme inducers and inhibitors(carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine, rifabutin, and so on)
patients who are treated with a combination of Paxlovid or Azvudine.