Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

November 15, 2019 updated by: Sherief Abd-Elsalam, Tanta University

Comparative Study Between the Efficacy of Oral Gemifloxacin and Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Egypt
      • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with spontaneous bacterial peritonitis

Exclusion Criteria:

  • secondary peritonitis

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with resolution of infection
Time Frame: 6 months
the total number of patients with resolution of infection
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 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 30, 2028

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (ACTUAL)

November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBP new treatment

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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