Comparative Study of Secondary Prophylaxis for SBP (NCT06827756) | Clinical Trial Compass
CompletedPhase 4
Comparative Study of Secondary Prophylaxis for SBP
Egypt90 participantsStarted 2021-03-01
Plain-language 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.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence of Spontaneous Bacterial Peritonitis (SBP)