Back to resultsNorfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Primary Purpose
Spontaneous Bacterial Peritonitis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Norfloxacin
Itopride
Sponsored by
About this trial
This is an interventional prevention trial for Spontaneous Bacterial Peritonitis
Eligibility 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.
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Norfloxacin
Norfloxacin and Itopride
Arm Description
Norfloxacin 400 mg daily
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
Outcomes
Primary Outcome Measures
Number of bouts of recurrence during treatment.
The recurrence of infection during treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04161768
Brief Title
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Official Title
Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Norfloxacin
Arm Type
Active Comparator
Arm Description
Norfloxacin 400 mg daily
Arm Title
Norfloxacin and Itopride
Arm Type
Experimental
Arm Description
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
Intervention Type
Drug
Intervention Name(s)
Norfloxacin
Other Intervention Name(s)
Epinor
Intervention Description
Norfloxacin 400 mg daily
Intervention Type
Drug
Intervention Name(s)
Itopride
Other Intervention Name(s)
Ganaton
Intervention Description
Itopride 50 mg three times daily
Primary Outcome Measure Information:
Title
Number of bouts of recurrence during treatment.
Description
The recurrence of infection during treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief abd-elsalam, ass. prof.
Phone
00201147773440
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afaf Younes Mohammed Younes, Msc
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mona Ahmed Helmy Shehata, Prof.
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Organizational Affiliation
Tanta University - Tropical Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Norfloxacin With Itopride Versus Norfloxacin in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
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