Ascites, Cirrhoses, Liver, Spontaneous Bacterial Peritonitis
Conditions
Brief summary
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.
Interventions
Patients receiving Norfloxacin 400 Mg to prevent SBP
Patients receiving Nitazoxaide 500 Mg to prevent SBP
DRUGColistin
Patients receiving Colistin 15ml three times/ day to prevent SBP
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Spontaneous Bacterial Peritonitis (SBP) | Baseline, 3 months, and 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-Reactive Protein (CRP) Reduction | Baseline, 1 month, 3 months, and 6 months | 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. |
| White Blood Cell (WBC) Count Reduction | Baseline, 1 month, 3 months, and 6 months | 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. |
| Renal Function Stability | Baseline, 3 months, and 6 months | Definition: Prevention of renal impairment during treatment. Measurement: Serum Creatinine (mg/dL) and Blood Urea Nitrogen (BUN) (mg/dL). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (Safety Assessment) | Throughout study duration (0-6 months) | Definition: Frequency and severity of treatment-related side effects (e.g., diarrhea, nephrotoxicity, hypersensitivity reactions). Measurement: Patient-reported symptoms and clinical examination findings. |
Countries
Egypt
Outcome results
None listed