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NCT04161768 Clinical Trial

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

Spontaneous Bacterial Peritonitis Clinical Trial

Official title:
Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04161768
Other study ID # SBP Management
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2018
Est. completion date December 1, 2028

Study information
Verified date November 2019
Source Tanta University
Contact Sherief Abd-Elsalam, ass. prof.
Phone 00201147773440
Email sheriefabdelsalam@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 1, 2028
Est. primary completion date December 1, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Norfloxacin
Norfloxacin 400 mg daily
• Itopride
Itopride 50 mg three times daily

Locations
Country Name City State
Egypt Sherief Abd-Elsalam Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of bouts of recurrence during treatment. The recurrence of infection during treatment. 6 months
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