Comparing Norfloxacin with Itopride to Norfloxacin alone for preventing infections in liver disease patients
Official title: Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Run by Tanta University · NCT04161768 · Data updated 2026-11-12
This study tests if adding Itopride to Norfloxacin can better prevent infections in liver disease patients who have had a previous infection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Status | Recruiting |
| Started | December 1, 2018 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | November 13, 2019 |
| Trial ID | NCT04161768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are cirrhotic patients with ascites who have had previous episodes of spontaneous bacterial peritonitis.
✕Probably not a fit
Patients with allergies to the study drugs, recent antibiotic therapy, hepatocellular carcinoma, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial compares the effectiveness of Norfloxacin combined with Itopride against Norfloxacin alone in preventing spontaneous bacterial peritonitis (SBP) in cirrhotic patients with ascites who have previously experienced SBP. The study aims to determine if the addition of Itopride enhances the prophylactic benefits of Norfloxacin. It is a Phase 3 interventional trial, indicating a focus on evaluating the efficacy and safety of the treatment regimen in a larger patient population.
Why it matters
Potential benefit: If successful, this study could provide a more effective prophylactic treatment option for patients at risk of spontaneous bacterial peritonitis.
How similar studies have gone: Other studies have explored antibiotic prophylaxis for spontaneous bacterial peritonitis, but the specific combination of Norfloxacin and Itopride is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * cirrhotic patients with ascites who had previous episodes of SBP. Exclusion Criteria: * 1\. Allergy or contraindication for the used drugs. 2. Recent antibiotics therapy in the previous 2 weeks. 3. Patients with hepatocellular carcinoma or other neoplasia. 4. Pregnant and lactating women.
Where it's running
-
Sherief Abd-Elsalam
Tanta, Egypt Recruiting
Study contacts
- Principal investigator: Afaf Younes Mohammed Younes, Msc — Tanta University - Faculty of Medicine
- Study coordinator: Sherief Abd-Elsalam, ass. prof.
- Email: sheriefabdelsalam@yahoo.com
- Phone: 00201147773440
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.