Comparative Study of Secondary Prophylaxis for SBP

Phase 4

Completed

• Conditions: Spontaneous Bacterial Peritonitis; Cirrhoses, Liver; Ascites
• Interventions: Drug: Norfloxacin 400 MG; Drug: Nitazoxanide 500 MG; Drug: Colistin

• Registration Number: NCT06827756
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norfloaxcin arm	Norfloxacin 400 MG	patients to receive norflxacin 400mg daily
Nitazoxaide arm	Nitazoxanide 500 MG	patients to receive nitazoxaide 500mg daily
Colisitn arm	Colistin	patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Tanta University, Faculty of Medicine; 🇪🇬 Tanta, Egypt