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

Last updated: February 14, 2024
Sponsor: People's Hospital of Zhengzhou University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Systemic Fungal Infections

Treatment

other antifungal agents,breathing machine

Clinical Study ID

NCT06137690
LJzhou
  • Ages 18-98
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 andinhibitors(carbamazepine, phenobarbital, phenytoin, cimetidine, rifampin, rifapentine,rifabutin, and so on)
  • patients who are treated with a combination of Paxlovid or Azvudine.

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: other antifungal agents,breathing machine
Phase:
Study Start date:
July 01, 2018
Estimated Completion Date:
March 01, 2024

Study 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.

Connect with a study center

  • Zhengzhou Central Hospital affiliated to Zhengzhou University

    Zhengzhou, Henan 41
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.