Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients
NCT ID: NCT06137690
Last Updated: 2024-02-16
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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RECRUITING
550 participants
OBSERVATIONAL
2018-07-01
2024-03-01
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 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A
the elderly group , the age ≥ 60 years
other antifungal agents,breathing machine
If treatment failure for patients in group A and group B，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
the non-elderly group , the age \< 60 years
other antifungal agents,breathing machine
If treatment failure for patients in group A and group B，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 and group B，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
* age ≥ 18 years
* The duration of VCZ treatment course ≥ 7 days.
Exclusion Criteria
* 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.
18 Years
98 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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Central Contacts
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Facility Contacts
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Other Identifiers
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LJzhou
Identifier Type: -
Identifier Source: org_study_id
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