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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04161768
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
120
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 1, 2028

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of bouts of recurrence during treatment. [6 months]

      The recurrence of infection during treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04161768
    Other Study ID Numbers:
    • SBP Management
    First Posted:
    Nov 13, 2019
    Last Update Posted:
    Nov 13, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peritonitis
    Norfloxacin

    Study Results

    No Results Posted as of Nov 13, 2019