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Study on the correlation between the voriconazole serum concentration and efficacy and side effects of voriconazole tablets in the prevention of invasive fungal infection in hematologic patients with agranulocytosis

Study on the correlation between the voriconazole serum concentration and efficacy and side effects of voriconazole tablets in the prevention of invasive fungal infection in hematologic patients with agranulocytosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030980
Enrollment
Unknown
Registered
2020-03-20
Start date
2020-04-02
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hematologic patients

Interventions

Case series:no

Sponsors

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with signing of informed consent and confirming to enrollment; 2. Length of stay >72h 3. Patients experience agranulocytosis or neutrophil count (ANC)was expected to decrease to <= 0.5*10^9/L within the next 48 hours, 4. Voriconazole was administered at least for 3 days 5. Male or femaleaged 15-70years and 12 to 14 years of age weighing greater than or equal to 50 kg.

Exclusion criteria

Exclusion criteria: (1) There was evidence of active fungal infection within 3 weeks before enrollment. (2) History of allergic to voriconazole; (3) Drug intolerance; don't obey the medication guide; (4) The severe liver function and renal function; (5) With acute hepatitis or chronic liver disease; (6) Pregnant or lactating women; (7) Combination of rifampicin and isoniazid phenytoin, carbamazepine, long-acting barbiturate;

Design outcomes

Primary

MeasureTime frame
Voriconazole plasma concentration;the polymorphism of CYP2C19 gene;

Secondary

MeasureTime frame
breakthrough infection rate;adverse event incidenceciyao;

Contacts

Public ContactJIANG,ErLie

Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

jiangerlie@163.com+86 15122538106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026