Comparative Study of Secondary Prophylaxis for SBP

Tanta University90 enrolled

Overview

The goal of this clinical trial is to learn if norfloxacin, nitazoxanide, and colistin work as secondary prophylactic agents for spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites. It also aims to evaluate the safety and effectiveness of these treatments. The main questions it aims to answer are: Are nitazoxanide and colistin as effective as norfloxacin in preventing recurrent SBP? What medical outcomes do participants experience when taking norfloxacin, nitazoxanide, or colistin? Researchers will compare norfloxacin, nitazoxanide, and colistin to determine their effectiveness in preventing SBP recurrence in cirrhotic patients. Participants will: Be randomly assigned to receive either 400 mg norfloxacin daily, 500 mg nitazoxanide twice daily, or 15 ml colistin syrup three times daily (2.25 MIU total per day). Undergo regular blood tests and ascitic fluid analysis at discharge, 2 months, and 6 months post-treatment. Be monitored for any side effects and recurrence of SBP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Spontaneous Bacterial Peritonitis Cirrhoses, Liver Ascites

Interventions

Norfloxacin 400 MGDRUG

Patients receiving Norfloxacin 400 Mg to prevent SBP

Nitazoxanide 500 MGDRUG

Patients receiving Nitazoxaide 500 Mg to prevent SBP

ColistinDRUG

Patients receiving Colistin 15ml three times/ day to prevent SBP

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response. * Ascitic patients diagnosed with Spontaneous Bacterial Peritonitis (SBP) by paracentesis. * Ascitic fluid polymorphonuclear (PMN) cell count \> 250/mm³. * Age 50 years to 80 years. * Willing to provide informed consent. Exclusion Criteria: * Pregnant or breastfeeding females. * History of allergic reactions to Norfloxacin, Nitazoxanide, or Colistin. * Patients with recurrent spontaneous peritonitis. * Presence of gastrointestinal hemorrhage. * Renal failure (Creatinine \> 2 mg/dL or on dialysis). * Presence of severe infection-related sequelae (e.g., persistent fever, abdominal discomfort, sepsis).

Outcomes

Primary Outcomes

Recurrence of Spontaneous Bacterial Peritonitis (SBP)

Definition: The percentage of patients experiencing a recurrence of SBP within 6 months of treatment initiation. Measurement: Diagnosis confirmed by ascitic fluid analysis (PMN count \> 250 cells/mm³ and positive culture).

Time frame: Baseline, 3 months, and 6 months

Secondary Outcomes

C-Reactive Protein (CRP) Reduction

Definition: A decrease in CRP levels, indicating a reduction in systemic inflammation. Measurement: CRP levels measured in mg/L. Success Criteria: A ≥50% reduction in CRP within 3 months is considered a positive response.

Time frame: Baseline, 1 month, 3 months, and 6 months

White Blood Cell (WBC) Count Reduction

Definition: Reduction in WBC count as a marker of infection control. Measurement: WBC count measured in x10³/µL. Success Criteria: A return to normal WBC count (\<10,000/µL) by 3 months.