- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161768
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
-
-
-
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
|
Norfloxacin 400 mg daily
Other Names:
|
EXPERIMENTAL: Norfloxacin and Itopride
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
|
Norfloxacin 400 mg daily
Other Names:
Itopride 50 mg three times daily
Other Names:
|
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
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
- Digestive System Diseases
- Infections
- Peritoneal Diseases
- Intraabdominal Infections
- Peritonitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Norfloxacin
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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