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NCT Number: NCT06827756

Comparative Study of Secondary Prophylaxis for SBP

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.

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Key information

Conditions

Spontaneous Bacterial Peritonitis Ascites Cirrhoses, Liver Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University, Faculty of Medicine

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Norfloxacin 400 MG

Drug

Patients receiving Norfloxacin 400 Mg to prevent SBP

Nitazoxanide 500 MG

Drug

Patients receiving Nitazoxaide 500 Mg to prevent SBP

Colistin

Drug

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

Primary outcomes

  1. Recurrence of Spontaneous Bacterial Peritonitis (SBP)

    Time frame: 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 outcomes

  1. C-Reactive Protein (CRP) Reduction

    Time frame: 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.

  2. White Blood Cell (WBC) Count Reduction

    Time frame: 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.

  3. Renal Function Stability

    Time frame: 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 outcomes

  1. Adverse Events (Safety Assessment)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: 3C-SPS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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