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RecruitingNCT04168099Updated Nov 19, 2019

Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis

A Phase 3 interventional study of Cefotaxime and Gemifloxacin in Spontaneous Bacterial Peritonitis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by Tanta University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Dec 2018, registered Nov 2019).
  • Started Dec 2018; still recruiting 7 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

oral Gemifloxacin versus intravenous Cefotaxime in treatment of spontaneous bacterial peritonitis

Read the detailed description

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

02

Conditions studied

  • Spontaneous Bacterial Peritonitis

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03

In context

Peritonitis

167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.

This study's planned enrollment of 60 is below the median of 79 across 106 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with spontaneous bacterial peritonitis

Exclusion criteria

Exclusion Criteria:

  • secondary peritonitis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Cefotaxime

    Cefotaxime intravenous

    Drug: Cefotaxime

  • Active comparator
    Gemifloxacin

    Oral Gemifloxacin

    Drug: Gemifloxacin

Interventions

  • Cefotaxime IV

    Also known as: cefotax, claforan

  • DrugGemifloxacin

    Gemifloxacin oral

    Also known as: gemiflox

06

What researchers measure

Primary outcomes

  1. Number of patients with resolution of infection

    the total number of patients with resolution of infection

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04168099
Lead sponsor
Tanta University
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Principal investigator
First posted
Nov 19, 2019
Start date
Dec 1, 2018
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Nov 19, 2019

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
sherief abd-elsalam, ass. prof.
Contact
sherif_tropical@yahoo.com
00201147773440
Hala Shaaban El Gendy, Msc
principal investigator · Tanta University - Faculty of Medicine
Osama El Sayed Negm, Prof.
principal investigator · Tropical Medicine Dept.-Tanta University - Faculty of Medicine
Sherief Abd-Elsalam, Ass. Prof.
principal investigator · Tropical Medicine Dept.-Tanta University - Faculty of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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