NCT02388035

Brief Summary

Spontaneous bacterial peritonitis (SBP) is a serious complication in cirrhotic patients, and the changes in the microbiological characteristics reported in the last years are impacting the choice of antibiotic used in the treatment. Cefotaxime has been the most extensively studied antibiotic for this infection. It is considered to be one of the first choice antibiotics because of low toxicity and excellent efficacy. Treatment of SBP by intravenous cefotaxime should be administered for a minimum 5 days. Antibiotic-resistant microorganisms have been increasingly reported especially to cefotaxime and its effect on the clinical outcome in treating SBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 months

First QC Date

March 9, 2015

Last Update Submit

June 3, 2015

Conditions

Spontaneous Bacterial Peritonitis

Keywords

profiles changesmicroorganismscefotaximeSBPEgyptianeffective antibiotics

Outcome Measures

Primary Outcomes (1)

  • Organisms detected with their antibiotics sensitivity

    8 months

Study Arms (4)

SBP-group 1

EXPERIMENTAL

Spontanous bacterial peritonitis

Drug: Cefotaxime

CNNA-group 2

EXPERIMENTAL

Culture negative neutrocytic ascites

Drug: Cefotaxime

MNBA-group 3

EXPERIMENTAL

monomicrobial non-neutrocytic ascites

Drug: Cefotaxime

group 4

NO INTERVENTION

no evidence of ascitic fluid infection

Interventions

CefotaximeDRUG
CNNA-group 2MNBA-group 3SBP-group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with liver cirrhosis and ascites and clinical findings suspicious of ascitic fluid infection

You may not qualify if:

  • Patients were excluded if they received antibiotics ten days prior to the hospital admission or there is evidence of secondary bacterial peritonitis, tuberculous peritonitis, malignant ascites or ascites due to other causes e.g. cardiac or renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasser institute

Cairo, Shubra, Egypt

Location

MeSH Terms

Interventions

Cefotaxime

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 13, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

EG(1)