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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04161768
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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Brief Summary:
Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis

Condition or disease Intervention/treatment Phase
Spontaneous Bacterial Peritonitis Drug: Norfloxacin Drug: Itopride Phase 3

Detailed Description:
Comparative Study of Norfloxacin versus Norfloxacin with Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study of Norfloxacin Versus Norfloxacin With Itopride in Secondary Prophylaxis of Spontaneous Bacterial Peritonitis
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2028
Estimated Study Completion Date : December 1, 2028
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Norfloxacin
Norfloxacin 400 mg daily
 Drug: Norfloxacin
Norfloxacin 400 mg daily
Other Name: Epinor
Experimental: Norfloxacin and Itopride
Norfloxacin 400 mg daily and Itopride 50 mg three times daily.
 Drug: Norfloxacin
Norfloxacin 400 mg daily
Other Name: Epinor

Drug: Itopride
Itopride 50 mg three times daily
Other Name: Ganaton


Outcome Measures
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Primary Outcome Measures :
  1. Number of bouts of recurrence during treatment. [ Time Frame: 6 months ]
    The recurrence of infection during treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161768


Contacts
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Contact: Sherief Abd-Elsalam, ass. prof. 00201147773440 sheriefabdelsalam@yahoo.com
Contact: sherief abd-elsalam, ass. prof. 00201147773440 sherif_tropical@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-Elsalam         
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Afaf Younes Mohammed Younes, Msc Tanta University - Faculty of Medicine
Principal Investigator: Mona Ahmed Helmy Shehata, Prof. Tanta University - Faculty of Medicine
Principal Investigator: Sherief Abd-Elsalam, Ass. Prof. Tanta University - Tropical Medicine Department
More Information
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT04161768    
Other Study ID Numbers: SBP Management
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infections
Peritoneal Diseases
Digestive System Diseases
Norfloxacin
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors