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Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04168099
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
121
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Comparative Study between the Efficacy of oral Gemifloxacin and intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Study Between the Efficacy of Oral Gemifloxacin and Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Actual Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Dec 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cefotaxime

Cefotaxime intravenous

Drug: Cefotaxime
Cefotaxime IV
Other Names:
  • cefotax, claforan

    		•
    Active Comparator: Gemifloxacin

    Oral Gemifloxacin

    Drug: Gemifloxacin
    Gemifloxacin oral
    Other Names:
  • gemiflox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with resolution of infection [6 months]

      the total number of patients with resolution of infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with spontaneous bacterial peritonitis
    Exclusion Criteria:
    • secondary peritonitis

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: Hala Shaaban El Gendy, Msc, Tanta University - Faculty of Medicine
    • Principal Investigator: Osama El Sayed Negm, Prof., Tropical Medicine Dept.-Tanta University - Faculty of Medicine
    • Principal Investigator: Sherief Abd-Elsalam, Ass. Prof., Tropical Medicine Dept.-Tanta University - Faculty of Medicine

    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:
    NCT04168099
    Other Study ID Numbers:
    • SBP new treatment
    First Posted:
    Nov 19, 2019
    Last Update Posted:
    Nov 19, 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
    Cefotaxime
    Cefoxitin
    Gemifloxacin

    Study Results

    No Results Posted as of Nov 19, 2019