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Comparison of voriconazole and caspofungin in the treatment of pulmonary fungal infection in HBV-associated ACLF

The research and application of new technology,new equipment and new scheme of the diagnosis and treatment of Severe hepatitis B(liver failure)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025250
Enrollment
Unknown
Registered
2019-08-17
Start date
2019-08-15
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

HBV-ACLF

Interventions

voriconazole group:Voriconazole 6mg/kg is given intravenously in the first 24 hours q12h. The dose will be changed to 4mg/kg qd 24 hours later (equivalent to 200mg qd) and serum voriconazole concentr
caspofungin group:Caspofungin intravenous infusion 70mg qd for the first dose, then continuous 50mg qd for more than two weeks.

Sponsors

Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The patient agrees to participate in the study and sign an informed consent form; 2. Male and female aged 18-65 years old; 3. HBsAg positive for more than 6 months and HBV-DNA positive (higher than 1000copies/ml or 200 IU/ml); 4. Extremely weak, and have obvious gastrointestinal symptoms such as anorexia, abdominal distension, nausea, and vomiting; 5. The jaundice is progressively deepened in the short term (the serum total bilirubin is greater than 10 times the upper limit of normal or daily increase is >=17.1umol/L); 6. The bleeding tendency is obvious, PTA<=40%, and other reasons are excluded; 7. Less than or equal to 1 organ dysfunction except for the criteria in items 5) and 6) above (1 organ dysfunction is occupied by fungal infection causing hypoxia and exponential decline)8) Patients with chronic liver disease based on chronic liver disease have not been diagnosed with cirrhosis.9) Screening for sputum fungus smear, fungal culture positive, or pulmonary imaging in response to fungal infection imaging changes10) Continuous treatment for 7 days and above and at the same time meet the fungal smear, fungal culture positive + G / GM test positive + pulmonary imaging changes, clinical diagnosis of pulmonary fungal infection, included in the study and follow-up study follow-up; otherwise No longer included in the study.

Exclusion criteria

Exclusion criteria: 1. Acute pregnancy fatty liver; 2. drug-induced liver damage; 3. Alcoholic liver disease; 4. autoimmune liver disease; 5. Congenital metabolic liver disease, such as wilson disease, hemochromatosis, etc.; 6. Hepatitis B recurrence after transplantation leads to severe hepatitis; 7. Concomitant with other viral infections (anti-HAV IgM, anti-HCV, anti-HEV IgM, anti-HEV-IgG, anti-HDV-IgM, and anti-HIV antibodies); 8. Associated with severe underlying diseases, including uncontrolled clinically significant heart, lung, kidney, digestive, neurological, psychiatric, immunological, metabolic, or malignant tumors.

Design outcomes

Primary

MeasureTime frame
Survival Rate;

Countries

China

Contacts

Public ContactJianrong Huang

The First Affiliated Hospital, College of Medicine, Zhejiang University

hzhuangchina@sina.com+86 13777453438

Outcome results

None listed

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