Comparative Study of Secondary Prophylaxis for SBP (3C-SPS)

Comparative Study Between Norfloxacin, Nitazoxanide and Colistin As Secondary Prophylactic Agents for Spontaneous Bacterial Peritonitis

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 Overview

• Status: Completed
• Conditions: Ascites; Spontaneous Bacterial Peritonitis; Cirrhoses, Liver
• Intervention / Treatment: Drug: Norfloxacin 400 MG; Drug: Nitazoxanide 500 MG; Drug: Colistin

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • tanta university, faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Norfloaxcin arm; patients to receive norflxacin 400mg daily	Drug: Norfloxacin 400 MG; Patients receiving Norfloxacin 400 Mg to prevent SBP
Active Comparator: Nitazoxaide arm; patients to receive nitazoxaide 500mg daily	Drug: Nitazoxanide 500 MG; Patients receiving Nitazoxaide 500 Mg to prevent SBP
Active Comparator: Colisitn arm; patients to receive Colistin 15 ml three times daily, totalling 2,25 MIU/ day	Drug: Colistin; Patients receiving Colistin 15ml three times/ day to prevent SBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, 1 month, 3 months, and 6 months
Renal Function Stability	Definition: Prevention of renal impairment during treatment. Measurement: Serum Creatinine (mg/dL) and Blood Urea Nitrogen (BUN) (mg/dL).	Baseline, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (Safety Assessment)	Definition: Frequency and severity of treatment-related side effects (e.g., diarrhea, nephrotoxicity, hypersensitivity reactions). Measurement: Patient-reported symptoms and clinical examination findings.	Throughout study duration (0-6 months)

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Digestive System Diseases; Liver Diseases; Peritoneal Diseases; Fibrosis; Intraabdominal Infections; Liver Cirrhosis; Ascites; Peritonitis; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Antiparasitic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Colistin; Nitazoxanide; Norfloxacin
• Other Study ID Numbers: 33045/04/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No