Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Phase 3

Recruiting

• Conditions: Spontaneous Bacterial Peritonitis
• Interventions: Drug: Norfloxacin; Drug: Itopride

• Registration Number: NCT04161768
• Lead Sponsor: Tanta University

Brief Summary

Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Detailed Description

Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-10
• Last Update Submitted: 2019-11-10
• Study First Posted: 2019-11-13
• Last Update Posted: 2019-11-13
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norfloxacin	Norfloxacin	Norfloxacin 400 mg daily
Norfloxacin and Itopride	Itopride	Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
Norfloxacin and Itopride	Norfloxacin	Norfloxacin 400 mg daily and Itopride 50 mg three times daily.

Primary Outcome Measures

Name	Time	Method
Number of bouts of recurrence during treatment.	6 months	The recurrence of infection during treatment.

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Tanta, Egypt