Back to resultsOral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Primary Purpose
Spontaneous Bacterial Peritonitis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cefotaxime
Gemifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Bacterial Peritonitis
Eligibility Criteria
Inclusion Criteria:
- Patients with spontaneous bacterial peritonitis
Exclusion Criteria:
- secondary peritonitis
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cefotaxime
Gemifloxacin
Arm Description
Cefotaxime intravenous
Oral Gemifloxacin
Outcomes
Primary Outcome Measures
Number of patients with resolution of infection
the total number of patients with resolution of infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04168099
Brief Title
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Official Title
Comparative Study Between the Efficacy of Oral Gemifloxacin and Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis
Detailed Description
Comparative Study between the Efficacy of oral Gemifloxacin and intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cefotaxime
Arm Type
Experimental
Arm Description
Cefotaxime intravenous
Arm Title
Gemifloxacin
Arm Type
Active Comparator
Arm Description
Oral Gemifloxacin
Intervention Type
Drug
Intervention Name(s)
Cefotaxime
Other Intervention Name(s)
cefotax, claforan
Intervention Description
Cefotaxime IV
Intervention Type
Drug
Intervention Name(s)
Gemifloxacin
Other Intervention Name(s)
gemiflox
Intervention Description
Gemifloxacin oral
Primary Outcome Measure Information:
Title
Number of patients with resolution of infection
Description
the total number of patients with resolution of infection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with spontaneous bacterial peritonitis
Exclusion Criteria:
secondary peritonitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
sherief abd-elsalam, ass. prof.
Phone
00201147773440
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Shaaban El Gendy, Msc
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama El Sayed Negm, Prof.
Organizational Affiliation
Tropical Medicine Dept.-Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Organizational Affiliation
Tropical Medicine Dept.-Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis
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