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A randomized controlled trial of prophylactic antimicrobial therapy in patients with chronic hepatitis B and hyperbilirubinemia

A randomized controlled trial of prophylactic antimicrobial therapy in patients with chronic hepatitis B and hyperbilirubinemia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024191
Enrollment
Unknown
Registered
2019-06-29
Start date
2019-07-01
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

Viral hepatitis

Interventions

experimental group: integrated therapy combined with prophylactic antimicrobial therapy
control group: integrated therapy

Sponsors

Third Affiliated Hospital of Sun Yet-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years (including 18 and 65 years), men and women are not restricted; 2. HBsAg positive lasting at least 6 months; 3. Acute onset, ALT is more than 5 times the upper limit of normal value; 4. Serum total bilirubin (TB) reached 10-20 times the normal upper limit (10-20ULN); 5. The plasma prothrombin activity (PTA) was more than 40%; 6. Patients are capable and willing to provide informed consent and comply with the test requirements.

Exclusion criteria

Exclusion criteria: 1. Severe liver function damage can reach the diagnostic criteria for liver failure or decompensated cirrhosis; 2. Combined with any definite infection basis, or WBC > 10 x 10^9/L, the proportion of neutrophils is more than 75%; 3. Corticosteroids or antibiotics were used before hospitalization; 4. People with a history of severe basic diseases that is considered unsuitable for the study; 5. People with a history of allergy to a variety of antimicrobial agents; 6. Other causes of liver damage, such as autoimmune liver disease, drug-induced hepatitis, acute hepatitis E, alcoholic hepatitis.

Design outcomes

Primary

MeasureTime frame
Incidence of liver failure within 4 weeks;Decline rate of serum total bilirubin within 4 weeks;

Secondary

MeasureTime frame
The length of hospital stay;Procalcitonin;

Countries

China

Contacts

Public ContactZiying Lei

The Third Affiliated Hospital of Sun Yet-Sen University

leiziy@mail.sysu.edu.cn+86 18902264273

Outcome results

None listed

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