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

Tanta University

Status and phase: Completed; Phase 4

Conditions: Spontaneous Bacterial Peritonitis; Ascites; Cirrhoses, Liver

Treatments: Drug: Nitazoxanide 500 MG; Drug: Colistin; Drug: Norfloxacin 400 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06827756

33045/04/19

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Norfloaxcin arm

Active Comparator group

Description:

patients to receive norflxacin 400mg daily

Treatment:

Drug: Norfloxacin 400 MG

Nitazoxaide arm

Active Comparator group

Description:

patients to receive nitazoxaide 500mg daily

Treatment:

Drug: Nitazoxanide 500 MG

Colisitn arm

Active Comparator group

Description:

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

Treatment:

Drug: Colistin