Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

NCT ID: NCT04168099

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2028-12-30

Brief Summary

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oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Detailed Description

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

Conditions

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Spontaneous Bacterial Peritonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cefotaxime

Cefotaxime intravenous

Group Type EXPERIMENTAL

Cefotaxime

Intervention Type DRUG

Cefotaxime IV

Gemifloxacin

Oral Gemifloxacin

Group Type ACTIVE_COMPARATOR

Gemifloxacin

Intervention Type DRUG

Gemifloxacin oral

Interventions

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Cefotaxime

Cefotaxime IV

Intervention Type DRUG

Gemifloxacin

Gemifloxacin oral

Intervention Type DRUG

Other Intervention Names

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cefotax, claforan gemiflox

Eligibility Criteria

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Inclusion Criteria

* Patients with spontaneous bacterial peritonitis

Exclusion Criteria

* secondary peritonitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hala Shaaban El Gendy, Msc

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Medicine

Osama El Sayed Negm, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tropical Medicine Dept.-Tanta University - Faculty of Medicine

Sherief Abd-Elsalam, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tropical Medicine Dept.-Tanta University - Faculty of Medicine

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

sherief abd-elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam

Role: primary

Other Identifiers

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SBP new treatment

Identifier Type: -

Identifier Source: org_study_id

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