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Primary Norfloxacin Prophylaxis for APASL-Defined Acute-on-Chronic Liver Failure: A Placebo-Controlled Double-Blind
Anand V Kulkarni1, Sowmya Tirumalle1, Madhumita Premkumar2
1Department of Hepatology, AIG Hospitals, Hyderabad, India.
The American Journal of Gastroenterology
|January 18, 2022
Summary
Prophylactic norfloxacin significantly reduced bacterial infections in patients with acute-on-chronic liver failure (ACLF). While not statistically significant, norfloxacin showed a trend toward improved transplant-free survival (TFS) in ACLF patients.
Area of Science:
- Hepatology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Acute-on-chronic liver failure (ACLF) is associated with a high risk of bacterial infections.
- Bacterial infections in ACLF patients contribute to disease progression and poor outcomes.
- Prophylactic antibiotics are considered to mitigate infection risk in vulnerable patient populations.
Purpose of the Study:
- To evaluate the efficacy of prophylactic norfloxacin in preventing bacterial infections in patients with ACLF.
- To assess the impact of norfloxacin prophylaxis on transplant-free survival (TFS) in ACLF patients.
- To analyze the incidence of bacterial infections and TFS at 30 and 90 days post-intervention.
Main Methods:
- A randomized controlled trial involving 143 ACLF patients.
- Patients received either oral norfloxacin (400 mg once daily for 30 days) or a placebo.
- Primary outcome: incidence of bacterial infections; Secondary outcome: transplant-free survival (TFS) at 30 and 90 days.
Main Results:
- Norfloxacin significantly reduced bacterial infections at day 30 (18.1% vs 33.8%, P=0.03) and day 90 (46% vs 62%, P=0.02).
- TFS showed a trend towards improvement with norfloxacin at day 30 (77.8% vs 64.8%, P=0.084) and day 90 (58.3% vs 43.7%, P=0.058).
- Multidrug-resistant organisms caused 30% of infections; candiduria was more frequent in the norfloxacin group (25% vs 2.63%).
Conclusions:
- Prophylactic norfloxacin is effective in preventing bacterial infections in ACLF patients.
- Norfloxacin may offer a survival benefit, warranting further investigation.
- Careful monitoring for fungal infections and multidrug-resistant organisms is crucial during norfloxacin prophylaxis.
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