Comparative Study of Secondary Prophylaxis for SBP

NCT06827756 | Completed Phase 4

• 1 other identifier: 33045/04/19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Spontaneous Bacterial Peritonitis; Cirrhoses, Liver; Ascites

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 3 months, and 6 months

Secondary Outcomes (3)

• C-Reactive Protein (CRP) Reduction

  Baseline, 1 month, 3 months, and 6 months

• White Blood Cell (WBC) Count Reduction

  Baseline, 1 month, 3 months, and 6 months

• Renal Function Stability

  Baseline, 3 months, and 6 months

Other Outcomes (1)

• Adverse Events (Safety Assessment)

  Throughout study duration (0-6 months)

Study Arms (3)

Norfloaxcin arm

ACTIVE COMPARATOR

patients to receive norflxacin 400mg daily

Drug: Norfloxacin 400 MG

Nitazoxaide arm

ACTIVE COMPARATOR

patients to receive nitazoxaide 500mg daily

Drug: Nitazoxanide 500 MG

Colisitn arm

ACTIVE COMPARATOR

patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day

Drug: Colistin

Interventions

Norfloxacin 400 MG DRUG

Patients receiving Norfloxacin 400 Mg to prevent SBP

Norfloaxcin arm

Nitazoxanide 500 MG DRUG

Patients receiving Nitazoxaide 500 Mg to prevent SBP

Nitazoxaide arm

Colistin DRUG

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

Colisitn arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University, Faculty of Medicine

Tanta, Egypt

Location

MeSH Terms

Conditions

Ascites

Interventions

Norfloxacin; nitazoxanide; Colistin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

EG (1)