Evaluating Voriconazole Treatment in Elderly Patients with Fungal Infections
Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients: A Prospective Observational Study
This study is testing how well voriconazole works and its safety for elderly patients with serious fungal infections compared to younger patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 98 Years |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06137690 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the therapeutic drug monitoring and safety of voriconazole in critically ill elderly patients with invasive fungal infections. Conducted at Zhengzhou Central Hospital from July 2018 to June 2023, it compares the initial serum trough concentrations and risk factors for hepatotoxicity between elderly patients (aged 60 and above) and non-elderly patients. The study includes patients who have been treated with voriconazole for at least seven days and excludes those with certain contraindications. The goal is to enhance understanding of how age affects voriconazole treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill adult patients aged 60 years and older diagnosed with invasive fungal infections.
Not a fit: Patients who are allergic to voriconazole or those receiving other antifungal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and efficacy of voriconazole treatment in elderly patients with invasive fungal infections.
How similar studies have performed: While there have been studies on voriconazole, this specific focus on elderly patients and therapeutic drug monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Zhengzhou, Henan
- Zhengzhou Central Hospital affiliated to Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhou Li-juan Zhou Li-juan, master
- Email: zhou750423@126.com
- Phone: 13838014946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.