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Nitazoxanide in Prevention of Secondary Spontaneous Peritonitis

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04746937
Collaborator
(none)
60
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of NTZ as an adjuvant therapy in the secondary prevention of SBP in patient with cirrhosis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Double-Blind Placebo-Controlled studyRandomized Double-Blind Placebo-Controlled study
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Nitazoxanide in Secondary Prevention of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control Group

They will receive standard therapy plus placebo

Drug: Norfloxacin
Standard therapy
Active Comparator: Nitazoxanide Group

They will receive standard therapy plus nitazoxanide

Drug: Nitazoxanide
nitazoxanide adjuvant to standard therapy
Other Names:
  • NTZ

    • Drug: Norfloxacin
    Standard therapy

    Outcome Measures

    Primary Outcome Measures

    1. Prevention of Secondary Spontaneous Bacterial Peritonitis [3 months]

      Reduction in incidence of secondary Spontaneous Bacterial Peritonitis (SBP) compared to control group

    Secondary Outcome Measures

    1. Change in Biological Biomarkers [3 months]

      Measurement of Tumor necrosis factor alfa , Procalcitonin(PCT), C-Reactive protein(CRP) and Erythrocyte sedimentation rate(ESR) with further calculation of PEC index [PEC index = PCT × (ESR + CRP)] before and after trial period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis.
    Exclusion Criteria:
    • Exclusion criteria included active gastrointestinal bleeding Hepatic encephalopathy (>grade 2) Hepatocellular carcinoma (HCC) or other malignancies Allergy to used medications.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Study Director: Sahar M. Elhagar, Professor, Supervisor for my master degree

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eslam Mostafa Elasawy AlTaras, Clinical Pharmacist, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04746937
    Other Study ID Numbers:
    • NTZ in Prevention of SBP
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Peritonitis
    Nitazoxanide
    Norfloxacin

    Study Results

    No Results Posted as of Feb 10, 2021