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

November 10, 2019 updated by: Sherief Abd-Elsalam, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Norfloxacin
Norfloxacin 400 mg daily
Drug: Norfloxacin
Norfloxacin 400 mg daily
Other Names:
  • Epinor
EXPERIMENTAL: Norfloxacin and Itopride
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
Drug: Norfloxacin
Norfloxacin 400 mg daily
Other Names:
  • Epinor
Drug: Itopride
Itopride 50 mg three times daily
Other Names:
  • Ganaton

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of bouts of recurrence during treatment.
Time Frame: 6 months
The recurrence of infection during treatment.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Sherief Abd-Elsalam, Ass. Prof., Tanta University - Tropical Medicine Department
  • Principal Investigator: Afaf Younes Mohammed Younes, Msc, Tanta university - faculty of medicine
  • Principal Investigator: Mona Ahmed Helmy Shehata, Prof., Tanta university - faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2028

Study Completion (ANTICIPATED)

December 1, 2028

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 10, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBP Management

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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