Comparing Norfloxacin with Itopride to Norfloxacin alone for preventing infections in liver disease patients
Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
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 |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT04161768 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are cirrhotic patients with ascites who have had previous episodes of spontaneous bacterial peritonitis.
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.
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 performed: Other studies have explored antibiotic prophylaxis for spontaneous bacterial peritonitis, but the specific combination of Norfloxacin and Itopride is relatively novel.
Eligibility criteria
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 this trial is running
Tanta
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.