NCT04168099

Brief Summary

oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
33mo left

Started Dec 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2018Dec 2028

Study Start

First participant enrolled

December 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

10 years

First QC Date

November 15, 2019

Last Update Submit

November 15, 2019

Conditions

Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

  • Number of patients with resolution of infection

    the total number of patients with resolution of infection

    6 months

Study Arms (2)

Cefotaxime

EXPERIMENTAL

Cefotaxime intravenous

Drug: Cefotaxime

Gemifloxacin

ACTIVE COMPARATOR

Oral Gemifloxacin

Drug: Gemifloxacin

Interventions

CefotaximeDRUG

Cefotaxime IV

Also known as: cefotax, claforan
Cefotaxime
GemifloxacinDRUG

Gemifloxacin oral

Also known as: gemiflox
Gemifloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with spontaneous bacterial peritonitis

You may not qualify if:

  • secondary peritonitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Interventions

CefotaximeGemifloxacin

Intervention Hierarchy (Ancestors)

CephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNaphthyridinesFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

sherief abd-elsalam, ass. prof.

CONTACT

00201147773440sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

December 1, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)